Clinical Research Associate (CRA) (Evergreen)
Clinical Research Coordinator Job 16 miles from Denver
Clinical Research Associate (CRA) (Evergreen) page is loaded **Clinical Research Associate (CRA) (Evergreen)** **Clinical Research Associate (CRA) (Evergreen)** locations Taipei , Taipei City, Taiwan time type Full time posted on Posted 30+ Days Ago job requisition id R1448634 Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
• High School Diploma or equivalent Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
locations Taipei , Taipei City, Taiwan time type Full time posted on Posted 30+ Days Ago locations Taipei , Taipei City, Taiwan time type Full time posted on Posted 30+ Days Ago IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
Clinical Research Coordinator (Entry - Senior Level)
Clinical Research Coordinator Job 15 miles from Denver
Clinical Research Coordinator (Entry - Senior Level) - 35541 University Staff Description University of Colorado Anschutz Medical Campus School of Medicine | Department of Psychiatry | Division of Addiction Science, Prevention and Treatment Working Title: Clinical Research Coordinator (Entry - Senior Level)
Position: #00829020 - Requisition: #35541
Job Summary:
The Clinical Research Coordinator will be supporting several different research projects in the School of Medicine, Department of Psychiatry, Division of Addiction Science, Prevention and Treatment at the University of Colorado, Anschutz Medical Campus.
This position will support research projects in Principal Investigator Dr. Hollis Karoly's Lab or Principal Investigator Dr. Ruschelle Leone's Cannabis, Alcohol, and Sexual Assault Prevention (CASPr) Lab. The primary focus of Dr. Leone's research is to inform and develop evidence-based intervention programming to reduce alcohol-related intimate partner and sexual violence. The primary focus in Dr. Karoly's lab is to explore the neural, biological, and behavioral underpinnings of substance use and addictive disorders using a translational and interdisciplinary approach, with a particular focus on alcohol and cannabis. The successful applicant will have the opportunity to work on several NIH-funded projects, which involve the evaluation of intervention programming to reduce alcohol-related violence and use of alcohol administration laboratory paradigms to study the effects of alcohol on bystander intervention and intimate partner sexual violence among diverse populations (e.g., sexual minority couples). Other projects include laboratory studies involving administration of alcohol and cannabis, as well as studies using neuroimaging to test the effects of these substances on reward processing and other addiction-relevant constructs.
This position is an ideal opportunity for a candidate pursuing a career or planning an advanced degree in medicine, public health, clinical psychology, neuroscience, biomedical research, or related fields in the future.
Key Responsibilities:
Assist with the day-to-day operations of clinical research studies.
Assist with recruitment and pre-screening of study participants.
Coordinate and run research visits including alcohol self-administration sessions.
Perform data entry and quality assurance reviews on study databases.
Participate in weekly lab meetings with study PI, and research team.
Assist PI with data management and data analysis.
Assist PI with dissemination (i.e., manuscript preparation, conference presentations).
Aid in the collection and processing of biological samples and data.
Assist with regulatory maintenance of assigned clinical trials (IRB and FDA initial submissions, amendments, continuing reviews).
Work Location:
Onsite - this role is expected to work onsite and is located in Aurora, CO.
Why Join Us:
The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - University of Colorado Hospital (UCHealth) and Children's Hospital Colorado (CHCO) - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit *******************
The Department of Psychiatry is one of the largest units in the UCD-SOM and is comprised of 5 Divisions. The CU Department of Psychiatry sets the standard for Education and Training of leaders in psychiatry and mental health care, conducts ground-breaking Research that aims to eradicate suffering due to psychiatric and substance use disorders, provides ready access to state of-the-art mental health preventions and interventions across the continuum of care, and collaborates with the community and other key stakeholders to promote well-being among all Coloradans. We accomplish this vision in a manner that respects, values and advocates for the dignity and worth of each individual and family.
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22/year (maximum accrual 352 hours)
Sick Days: 15/year (unlimited maximum accrual)
Holiday Days: 10/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum Qualifications:
Entry Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Intermediate Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
One (1) year clinical research or related experience.
Senior Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Two (2) years clinical research or related experience.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
Bachelor's degree in science or health related field.
Three (3) years of clinical research or related experience.
Experience handling biohazardous materials such as human blood, urine, and saliva samples.
Experience conducting human subjects research visits or eligibility screenings.
Conditions of Employment:
Ability to work evenings and weekends as scheduled.
Knowledge, Skills, and Abilities:
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Strong organizational skills with the ability to multitask and meet deadlines.
Ability to work collaboratively with study staff, postdoctoral researchers, undergraduates, principal investigators, hospital, clinic, and lab staff.
Proficiency with Microsoft Office Suite programs.
Familiarity with REDCap/Qualtrics surveys and data entry.
How to Apply:
For full consideration, please submit the following document(s):
1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
2. Curriculum vitae / Resume
3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.
Questions should be directed to: Quinton Powell, HR Recruiter, ***************************************
Screening of Applications Begins:
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by December 19th, 2024. Those who do not apply by this date may or may not be considered.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as:
Entry Level: $47,743 - $60,729
Intermediate Level: $51,956 - $66,088
Senior Level: $56,169 - $71,447
The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator: *****************************
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ******************************** .
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Qualifications Application Materials Required: Cover Letter, Resume/CV, List of References Job Category: Research Services Primary Location: Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20921 - SOM-PSYCH-SUB-DEP SPG/GIFT Schedule: Full-time Posting Date: Nov 21, 2024 Unposting Date: Ongoing Posting Contact Name: Quinton Powell Posting Contact Email: *************************************** Position Number: 00829020
Assistant Clinical Research Coordinator - 133321
Clinical Research Coordinator Job 13 miles from Denver
**Filing Deadline: Wed 12/11/2024** **UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.**
*UCSD Layoff from Career Appointment*: Apply by 12/2/24. for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
*Special Selection Applicants*: Apply by 12/11/24. Eligible Special Selection clients should contact their Disability Counselor for assistance.
**DESCRIPTION**
The Department of Anesthesiology employs over 200 Academic and Staff personnel and has an annual operating budget of $83 million in annualized resources (School of Medicine and Clinical Practice Organization (CPO) between Practice Plan revenues, VA Medical Center funding, Hospital and Medical Group funding, UC Foundation, Research sources and School of Medicine funds. There are over 85 Clinical faculty, 20 Ph.D. faculty, 8 Post-Doctoral Scholars, 42 Residents, 8 Senior Clinical Fellows, 33 Certified Nurse Anesthetists, 1 Physician Assistant and five collective bargaining units represented. The Department provides Clinical Anesthesia, Critical Care and Pain Services in Hillcrest, Thornton Hospital, Shiley Eye Center, Rady Children's Hospital, Jacobs Medical Center and the VA Medical Center. The Department operates a Pain Clinic at Perlman. The Department's research programs include bench and clinical research programs located at the VA Medical Center, Medical Teaching Facility, Clinical Teaching Facility, Hillcrest, Thornton, Sanford Consortium of Regenerative Medicine facilities and the Altman CTRI.
Under supervision of Clinical Research Manager, the Assistant Clinical Research Coordinator will be assigned to coordinate multiple federally funded and industry sponsored research studies involving human subjects that are being conducted in the CTRI and at other locations. Assist with initiation, implementation and management of clinical trials. Ensure compliance with goals and objectives of research protocols and with state and federal regulatory guidelines. Duties include but not limited to: interpreting research protocols; recruiting subjects; screening for eligibility including obtaining vital signs, ECGs, height and weight; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data activities; processing and submitting laboratory specimens; collecting and entering research data; maintaining accurate and complete clinical research files and patient medical charts. Update study and patient records in the University approved Clinical Trial Management System (VELOS) on a consistent basis. Working directly with Human Research Protection Program (HRPP), submitting new protocol applications, amendments, safety reports and annual renewals, as needed. Act as liaison between Clinical Research Manager, Principal Investigator, the HRPP and study sponsors. Other duties assigned as needed.
**MINIMUM QUALIFICATIONS**
* Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or Bachelor's degree, and/or an equivalent combination of education and experience.
* Knowledge and experience of the clinical research setting, including protocols, principles, and standards. Demonstrated experience planning and performing clinical research studies.
* Ability to maintain subjects' confidentiality.
* Skills in administering study related questionnaires and assessments.
* Ability to work independently with limited supervision.
* Ability to communicate to supervisor, PI and research team study progress and accept constructive advice and suggestions.
* Ability to work with a diverse group of professionals, including physicians, other health care professionals and research subjects.
* Demonstrated ability to accurately collect, record, transcribe and synthesize clinical data while paying conscientious attention to details. Experience completing clinical trial forms via hard copy and/or online.
* Ability to understand and learn study procedures from protocols. Ability to problem-solve.
* Demonstrated ability to work with different clinical protocols concurrently.
* Experience with interpreting laboratory values to determine subject's eligibility and potential toxicities.
* Ability to understand and interpret complex research protocols in order to screen patients for eligibility, initiate study plan, collect data, evaluated for adverse events and protocol deviations.
* Knowledge in interpreting medical charts and extracting accurate data from medical records.
* Experience with handling laboratory samples and knowledge of shipping procedures.
* Knowledge of Human Subjects Protection requirements.
* Computer experience including Microsoft Office, database management and email skills.
* Must have current CPR certificate or ability to attain within 2 months of hire date.
**PREFERRED QUALIFICATIONS**
* Certification as a clinical research associate or coordinator.
* Experience performing venipuncture and California Venipuncture license. Acquired within 6 months of hire.
* Fluent in Spanish.
**SPECIAL CONDITIONS**
* Employment is subject to a criminal background check and pre-employment physical.
* Must be able to travel to different locations and work at different clinical sites.
* Must have access to reliable transportation.
* Willing to work evenings and weekends if needed.
* Must be willing to work with human samples, including blood, urine, tissue specimens, saliva, etc.if needed.
* Must have negative TB test prior to hire date.
*Pay Transparency Act*
Annual Full Pay Range: $66,753 - $107,407 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $31.97 - $51.44
Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
**If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.**
**If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.**
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an exte
Senior Clinical Research Scientist
Clinical Research Coordinator Job In Denver, CO
**Become a part of our caring community and help us put health first** Healthcare is rapidly changing, and our members are living longer, often with more chronic conditions. The Clinical Analytics team identifies opportunities and build solutions to improve clinical outcomes and lower costs for millions of Medicare Advantage beneficiaries leveraging data science & analytics, clinical expertise, strategic mindset, and rigorous study designs. In this multi-disciplinary team, you will have the opportunity to work closely with strategy partners and clinicians to shape Humana's future enterprise clinical strategies and initiatives.
The Senior Research Scientist applies mathematical, statistical, epidemiologic and data science principles to identify trends, assess variable associations or cause-effect relationships, and size potential opportunities to drive improvement in population health and reduction of healthcare cost using high volumes of structured and unstructured data.
The Senior Research Scientist will have the opportunity to exercise considerable latitude in determining objectives and approaches to assignments.
**Responsibilities**
As a Senior Research Scientist, you will:
+ Research, prototype and scale new ideas to impact population health and cost of healthcare
+ Collaborate with analytic and business teams to set objectives, approaches, and work plans
+ Leverage a wide range of analytics methods ranging from descriptive to prescriptive to transform high volumes of complex data into analytics solutions and actionable insights
+ Collaborate with clinicians and clinical informaticists to define various clinical concepts and extract clinical information from medical, pharmacy, and lab claims for analytics and modeling purposes
+ Translates analytic results into key takeaways and communicate to business partners
+ Understands department, segment, and organizational strategy and operating objectives, including their linkages to related areas
+ Make decisions regarding own work methods, occasionally in ambiguous situations with general guidance
**Use your skills to make an impact**
**Required Qualifications**
+ Master's Degree in a quantitative discipline such as Epidemiology, Biostatistics, Economics, Statistics, Clinical Informatics, Mathematics, Data Science, Data Analysis and/or related fields
+ Experience working with healthcare data and/or strong interest in healthcare and desire to make a positive impact on population health
+ 3-5 years of professional experience leveraging structured and unstructured data
+ Proficient in manipulating and analyzing data with at least one of the programming languages such as Python, R, SAS
+ Demonstrated strong analytical thinking and problem-solving skills
+ Clear and concise oral and written communication skills, with a proven ability to translate complex methodologies and analytical results to higher-level business insights and key takeaways
**Preferred Qualifications**
+ Healthcare or managed care working experience
+ Experience working with medical, pharmacy, lab claims
+ Experience working with big data and using PySpark, Spark R or Spark Scala
+ Experience with causal inference and causal machine learning techniques, and/or advanced machine learning algorithms such as deep learning, NLP, recommender system, network analysis.
+ Familiarity with clinical concepts related to a broad range of clinical conditions and disease states, such as oncology, falls, palliative care, behavioral health and/or other chronic conditions
+ Deep understanding of healthcare payer economics, and/or other specific healthcare areas such as EMR, Episode grouper, utilization management, value-based care, low value care etc.
+ Familiarity with clinical concepts related to a broad range of clinical conditions and disease states, such as oncology, falls, palliative care, behavioral health and other chronic conditions
**Scheduled Weekly Hours**
40
**Pay Range**
The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay will vary based on demonstrated job related skills, knowledge, experience, education, certifications, etc.
$93,000 - $128,000 per year
This job is eligible for a bonus incentive plan. This incentive opportunity is based upon company and/or individual performance.
**Description of Benefits**
Humana, Inc. and its affiliated subsidiaries (collectively, "Humana") offers competitive benefits that support whole-person well-being. Associate benefits are designed to encourage personal wellness and smart healthcare decisions for you and your family while also knowing your life extends outside of work. Among our benefits, Humana provides medical, dental and vision benefits, 401(k) retirement savings plan, time off (including paid time off, company and personal holidays, volunteer time off, paid parental and caregiver leave), short-term and long-term disability, life insurance and many other opportunities.
**About us**
Humana Inc. (NYSE: HUM) is committed to putting health first - for our teammates, our customers and our company. Through our Humana insurance services and CenterWell healthcare services, we make it easier for the millions of people we serve to achieve their best health - delivering the care and service they need, when they need it. These efforts are leading to a better quality of life for people with Medicare, Medicaid, families, individuals, military service personnel, and communities at large.
**Equal Opportunity Employer**
It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or veteran status. It is also the policy of Humana to take affirmative action to employ and to advance in employment, all persons regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.
Humana complies with all applicable federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, sex, sexual orientation, gender identity or religion. We also provide free language interpreter services. See our ***************************************************************************
Research Coordinator III
Clinical Research Coordinator Job In Denver, CO
DepartmentGrants and Sponsored Programs
We are seeking a collaborative team member in the Office of Sponsored Research and Programs. The Research Coordinator III will support and enable MSU Denver's mission by identifying new research funding opportunities and providing programs to help with grant seeking. Position will be based in a historic house on 9th Street on the Auraria Campus in Downtown Denver.
Join our team of dynamic administrators! We are seeking a collaborative team member in the Office of Sponsored Research and Programs. The Research Coordinator III will support and enable MSU Denver's mission by identifying new research funding opportunities and providing programs to help with grant seeking. Position will be based in the historic house on 9th Street on the Auraria Campus in Downtown Denver.
Operations
Perform funding searches and prospect research utilizing Proquest Pivot, AASCU Grant Resource Center, and other resources. Assist campus community with establishing personal profiles with funding databases.
Input proposal data and maintain internal records of grant awards in Cayuse grants management system.
Assist Assistant Director of Human Ethics/Subjects as necessary
Coordinate and perform day to day operational and administrative activities in support of research programs
Work cross-functionally with departments (pre-award, non-financial post-award, and human ethics), their leaders, and administrators in the department and in the University to move research related objectives forward
Cross-train with the proposal development specialists and serve as backup during extended absences
Assist OSRP Associate Director with planning and executing the annual OSRP PI Celebration event.
Prioritize and manage projects including taking initiative and working collaboratively to solve problems and resolve concerns
Plan monthly research administration activities and professional development
Reporting
Provide statistical information pertaining to proposals and awards, including contracts, and compile regular reports utilizing electronic spreadsheets and databases
Budgeting
Provide advanced level of support with the preparation and management of the OSRP departmental operating budgets
Review, process, and/or approve day-to-day business transactions with accuracy, completeness, and in compliance with university policies
Reconcile MSU Denver P-Card transactions for OSRP following MSU Denver/AHEC Policies and Procedures
Develop and establish procedures for the budget process and daily operations of OSRP according to policies and procedures established by the university and state procurement
Other
Other duties as assigned
Required Experience
Experience with both pre- and post-award research administration activities.
Experience working in a higher education setting.
Familiarity with federal granting agency policies and procedures, including 2 CFR 200 and research compliance requirements.
Excellent oral, written and interpersonal communication skills and presentations skills.
Accountability to follow through on commitments, strong organizational and project management skills, and ability to manage sensitive and financial information with confidentiality.
Attention to detail and collaborative team member
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Teams, and Outlook), Adobe Acrobat, web and electronic communications technologies
Bachelor's degree
Preferred Experience
Experience with both pre- and post-award research administration activities, ideally at least three years of experience in pre-award, research administration, and/or in the public service/non-profit sector, working on grants. Experience with instruction or training considered a plus.
Experience working with college/university faculty in a collaborative manner.
Familiarity with university accounting policies and procedures, including purchasing, travel, reimbursements, and cost transfers.
Proven ability to communicate and build rapport with university administrators and faculty.
High level of accuracy and attention to detail and knowledge of Microsoft Office (Word, Excel, PowerPoint, Teams, and Outlook), Adobe Acrobat, web and electronic communications technologies.
At least two years of experience with proposal submission and award management guidelines set forth by federal funding agencies.
Advance degree preferred.
Salary for Announcement
Under Colorado law, MSU Denver is required to provide a reasonable estimate of the compensation range for this role and should not offer a salary outside of the range posted in this job announcement. This range takes into account a variety of factors including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, analysis of internal equity, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience.
The salary range that the University reasonably expects to pay for this position is $49,900 - $62,400. The full salary range is $49,900 - $74,900.
This position is paid monthly and is eligible for MSU Denver benefits.
Work Hours
Full-time, 40 hours per week
Exempt
Days of the Week: Monday - Friday, 8am - 5pm
Evenings and Weekend Work: N/A
Schedule: in-person with the potential to work hybrid a couple of days a week. Visit our website for more information on our University's Alternative Work Arrangements policy.
Travel: Rarely
Instructions to Apply
Please apply through MSU Denver Careers and submit your cover letter and resume. Select Begin Your Job Search, then search for JR103085. Internal applicants must apply through their MSU Denver Workday profile by searching 'Find Jobs'. Applications that do not contain all required documents may not receive full consideration.
Full consideration to candidates who apply in the first 30 days by Wednesday, November 6, 2024 at 11:59pm.
Closing Date
Open Until Filled
Posting RepresentativeElizabeth WellingtonPosting Representative *************************** Benefits
The University's benefits package is comprehensive and offers medical, vision and dental, free RTD pass, tuition reimbursement, as well as a life and supplemental insurance plans, retirement plans and other programs, such as access to a long-term disability (LTD) plan. Visit MSU Denver's benefits website to learn more.
For a brief overview, please see: *****************************************************************************
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at **************************.
Diversity Statement
Metropolitan State University of Denver is a unique, access-oriented campus community that values diversity, equity, and inclusion in all its forms. Our student population consists of nearly 58% first generation students and over 50% students of color. We are a designated Hispanic Serving Institution located in downtown Denver.
We create an equitable learning and working environment in concert with individuals who consistently demonstrate commitment to equity and inclusion. We greatly value the diverse identities and perspectives of our students, faculty, and staff and recognize that in order to achieve a just and equitable society, diversity must go beyond simple representation. It requires critical inquiry and dialogue and a commitment to action. We strive to provide a culture of belonging for all community members to achieve personal and professional success.
Senior Clinical Project Manager
Clinical Research Coordinator Job In Denver, CO
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
**Job Overview**
Responsible for the planning, implementation, execution and management of multiple clinical studies and/or global studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations (CRO) if applicable.
**Job Duties and Responsibilities**
+ Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
+ Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
+ Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
+ Provides oversight and management of CROs, consultants and vendors.
+ Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
+ Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
+ Monitors the status of clinical data collection of assigned clinical trials.
+ Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
+ Prepares and reviews study-related documents when required.
+ Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
+ Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
+ Participates in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors' workshops and CRO Training.
+ Reviews correspondences and monitoring reports relating to the studies.
+ Prepare and deliver program/study updates.
+ Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
+ Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
+ Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
+ Provides input into contracts, work orders and/or change orders.
+ Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
+ Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
+ Ensures assigned studies adhere to all applicable regulations and requirements.
+ Provides input as the subject matter expert for the assigned studies during regulatory inspections.
+ Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
+ Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
+ Evaluate CRO and vendor performance and support the improvement initiatives.
+ Participate in the preparation, review, updating and training of SOPs.
+ Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
+ May Mentor other team members.
+ Perform other duties as requested by the senior management.
**Key Core Competencies**
+ Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
+ Demonstrated skills working within a matrix environment.
+ Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan.
+ Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
+ Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
+ Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
+ Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
+ Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
+ Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
+ Strong analytical skills with a data driven approach to planning, executing, and problem solving
+ Working knowledge of current global regulatory requirements and guidelines for clinical trials.
**Education and Experience**
+ S./M.S./Ph.D. in a related life science discipline is preferred.
+ Thorough understanding of the oncology arena.
+ Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
The base salary range for this role is $137,100 to $171,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer**
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (******************************************************************
EEO is the Law Poster Supplement
Pay Transparency (***********************************************************************************************
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Clinical Research Coordinator (Entry - Senior Level)
Clinical Research Coordinator Job 15 miles from Denver
University of Colorado Anschutz Medical Campus
School of Medicine | Department of Psychiatry | Division of Addiction Science, Prevention and Treatment
Working Title\: Clinical Research Coordinator (Entry - Senior Level)
Position\: #00829020 - Requisition\: #35541
Job Summary:
The Clinical Research Coordinator will be supporting several different research projects in the School of Medicine, Department of Psychiatry, Division of Addiction Science, Prevention and Treatment at the University of Colorado, Anschutz Medical Campus.
This position will support research projects in Principal Investigator Dr. Hollis Karoly's Lab or Principal Investigator Dr. Ruschelle Leone's Cannabis, Alcohol, and Sexual Assault Prevention (CASPr) Lab. The primary focus of Dr. Leone's research is to inform and develop evidence-based intervention programming to reduce alcohol-related intimate partner and sexual violence. The primary focus in Dr. Karoly's lab is to explore the neural, biological, and behavioral underpinnings of substance use and addictive disorders using a translational and interdisciplinary approach, with a particular focus on alcohol and cannabis. The successful applicant will have the opportunity to work on several NIH-funded projects, which involve the evaluation of intervention programming to reduce alcohol-related violence and use of alcohol administration laboratory paradigms to study the effects of alcohol on bystander intervention and intimate partner sexual violence among diverse populations (e.g., sexual minority couples). Other projects include laboratory studies involving administration of alcohol and cannabis, as well as studies using neuroimaging to test the effects of these substances on reward processing and other addiction-relevant constructs.
This position is an ideal opportunity for a candidate pursuing a career or planning an advanced degree in medicine, public health, clinical psychology, neuroscience, biomedical research, or related fields in the future.
Key Responsibilities:
Assist with the day-to-day operations of clinical research studies.
Assist with recruitment and pre-screening of study participants.
Coordinate and run research visits including alcohol self-administration sessions.
Perform data entry and quality assurance reviews on study databases.
Participate in weekly lab meetings with study PI, and research team.
Assist PI with data management and data analysis.
Assist PI with dissemination (i.e., manuscript preparation, conference presentations).
Aid in the collection and processing of biological samples and data.
Assist with regulatory maintenance of assigned clinical trials (IRB and FDA initial submissions, amendments, continuing reviews).
Work Location:
Onsite - this role is expected to work onsite and is located in Aurora, CO.
Why Join Us:
The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - University of Colorado Hospital (UCHealth) and Children's Hospital Colorado (CHCO) - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit *******************
The Department of Psychiatry is one of the largest units in the UCD-SOM and is comprised of 5 Divisions. The CU Department of Psychiatry sets the standard for Education and Training of leaders in psychiatry and mental health care, conducts ground-breaking Research that aims to eradicate suffering due to psychiatric and substance use disorders, provides ready access to state of-the-art mental health preventions and interventions across the continuum of care, and collaborates with the community and other key stakeholders to promote well-being among all Coloradans. We accomplish this vision in a manner that respects, values and advocates for the dignity and worth of each individual and family.
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
Medical\: Multiple plan options
Dental\: Multiple plan options
Additional Insurance\: Disability, Life, Vision
Retirement 401(a) Plan\: Employer contributes 10% of your gross pay
Paid Time Off\: Accruals over the year
Vacation Days\: 22/year (maximum accrual 352 hours)
Sick Days\: 15/year (unlimited maximum accrual)
Holiday Days\: 10/year
Tuition Benefit\: Employees have access to this benefit on all CU campuses
ECO Pass\: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum Qualifications:
Entry Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Intermediate Level\:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
One (1) year clinical research or related experience.
Senior Level:
Bachelor's degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Two (2) years clinical research or related experience.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
Bachelor's degree in science or health related field.
Three (3) years of clinical research or related experience.
Experience handling biohazardous materials such as human blood, urine, and saliva samples.
Experience conducting human subjects research visits or eligibility screenings.
Conditions of Employment:
Clinical Research Coordinator/RN
Clinical Research Coordinator Job 15 miles from Denver
Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Clinical Research Coordinator/RN in Centennial. Bring your established Oncology and or Research experience and join a team dedicated to providing an excellent experience to patients.
We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It's much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.
No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient's hand, or a scheduler on the phone finding an appointment that fits into a patient's schedule, we are deeply connected to our patients and do what we can to help.
If this sounds like you, we'd love to have you join our team.
Salary Range: $60,000-$75,000 for non-nurses and $80,000-$97,000 for nurses
Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential for research bonus depending on financials of department after one year of employment; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance.
Pay is based on several factors including but not limited to education, work experience, certification, etc.
A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis.
Responsibilities
* Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
* Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
* Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
* Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
* Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
* May collaborate with Research Site Leader in the study selection process.
* Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors.
* Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
* May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
* May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
* Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Qualifications
* Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
* SoCRA or ACRP certification preferred.
or
* Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred.
* Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCPconcepts. -Experience with computer data entry and database management. -Excellent written and oral communication skills.
* Excellent organizational skills-Attention to details and accuracy-Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents. -Ability to work independently, organize, prioritize, and follow through with results.-Ability to solve practical problems and implement solutions.
Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)
Candidates will be required to show proof of being vaccinated against influenza upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.
All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.
We will be accepting applications on an ongoing basis for this position. To apply for this position, start the process by clicking the blue "apply" button.
Clinical Research Coordinator
Clinical Research Coordinator Job In Denver, CO
* Department Clinical Research Unit * Schedule - Shift - Hours Full Time - Day Shift: Monday - Friday * Job Category Clinical Research * Req #: 18738 - Consistently applies Clinical Research Guidelines including Good Clinical Practice, HIPAA regulations, CRS Standard Operating Procedures, applicable NJH Policies and Procedures, and FDA, NIH, OHRP, ICH guidelines as applicable.
- Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
- Independently performs study-related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies and NJH competency requirements.
- Complies with regulatory bodies to create and maintain study records, and if applicable, dispensation and accountability of investigational product.
- Efficiently implements and successfully executes complex research studies with high quality and appropriate enrollment.
- Provides general guidance to new staff and study coordinators.
- **Accountability:** Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
- **Adaptability:** Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
- **Attention to Detail:** Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
- **Champion of Change:** Facilitating the implementation and acceptance of change within the workplace. Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
- **Collaboration/Teamwork:** Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
- **Patient Relations:** Meeting patient and patient family needs; taking responsibility for a patient's safety, satisfaction, and clinical outcomes; using appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence.
- **Drive for Results:** Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
- **Professional Development or Continuous Learning and Development:** Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill to enhance their contribution to the organization.
- **Initiative:** Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
- Be available to work as scheduled and report to work on time.
- Be willing to accept supervision and work well with others.
- Be well groomed, appropriately for your role and wear ID Badge visibly.
- Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
- Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
- Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
- Wears appropriate PPE as outlined by the infection control policies and procedures.
- Demonstrates compliance with all state, federal and all other regulatory agency requirements.
- **Education:** Bachelor's degree required.
- **Work Experience:** A minimum of 1 year clinical research experience required.
- **Special Training, Certification or Licensure:** BLS required within one month of hire. CITI training required within one month of hire.
* **Comprehensive Medical Coverage:** Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans.
* **Paid Time Off:** Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations.
* **Dental & Vision Plans:** Coverage effective the first of the month after hire.
* **Retirement Savings:** 403(b) plan with employer contributions after two years.
* **Wellness Incentives:** Earn up to $200 annually for preventive health activities.
* **Tuition Reimbursement:** Up to $5,250 annually for full-time and part-time employees.
* **Child Care Assistance:** Childcare Flex Spending Account (FSA) with annual employer contribution.
* **Loan Forgiveness:** Public Service Loan Forgiveness (PSLF) eligible employer.
* **Disability & Life Insurance:** Employer-paid plans and optional buy-up choices.
* **Voluntary Benefits:** Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan
* **Exclusive Discounts:** Savings on local services, insurance, and RTD bus passes.
**Benefits**
At National Jewish Health, we recognize that our outstanding faculty and staff are the essence of our organization. For every aspect of health care, our employees are our greatest asset. With that in mind, we have designed a valuable, comprehensive benefits package to meet the needs of our employees and their families. * **Comprehensive Medical Coverage:** Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans.
* **Paid Time Off:** Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations.
* **Dental & Vision Plans:** Coverage effective the first of the month after hire.
* **Retirement Savings:** 403(b) plan with employer contributions after two years.
* **Wellness Incentives:** Earn up to $200 annually for preventive health activities.
* **Tuition Reimbursement:** Up to $5,250 annually for full-time and part-time employees.
* **Child Care Assistance:** Childcare Flex Spending Account (FSA) with annual employer contribution.
* **Loan Forgiveness:** Public Service Loan Forgiveness (PSLF) eligible employer.
* **Disability & Life Insurance:** Employer-paid plans and optional buy-up choices.
* **Voluntary Benefits:** Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan
* **Exclusive Discounts:** Savings on local services, insurance, and RTD bus passes.
Clinical Trial Manager - Denver, CO (Sign-On Bonus Eligible)
Clinical Research Coordinator Job In Denver, CO
**Clinical Trial Manager - Denver, CO** JOB\_DESCRIPTION.SHARE.HTML CAROUSEL\_PARAGRAPH JOB\_DESCRIPTION.SHARE.HTML * Denver, Colorado * Clinical Trial Management * 9783 Medpace is the leading CRO for Biotech companies and is continuing to add established Project Managers to join our Clinical Trial Management Group in **Denver, CO** . Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular/Metabolic, Infectious Disease, Neuroscience, and more. We have just expanded our campus in Cincinnati and have offices in Dallas and Denver and provide remote flexibility with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.
Responsibilities
* Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
* Serve as primary Sponsor contact for operational project-specific issues and study deliverables
* Maintain in depth knowledge of protocol, therapeutic area, and indication
* Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
* Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
* Develop operational project plans
* Manage risk assessment and execution
* Responsible for management of study vendor
* Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
Qualifications
* Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred
* Experience in Phases 1-4; Phases 2-3 preferred
* 5+ years as a project/clinical trial manager within a CRO; **required for home-based**
* Management of overall project timeline
* Strong leadership skills
**Compensation**
A target salary range of $100,000 - $190,000. Your compensation will be based on your skills and experience. Medpace offers the following benefits for eligible positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, and pet insurance. For more details, please discuss with your recruiter.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
**Denver Perks**
* Flexible work environment
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Structured career paths with opportunities for professional growth
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* RTD Eco Pass
* Secure bike storage room
**Awards**
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
**What to Expect Next**
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
Senior Clinical Research Associate
Clinical Research Coordinator Job In Denver, CO
Senior CRA
Responsibilities include:
* All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties
* All aspects of site and registry management as prescribed in the project plans
* Organize and make presentations at Investigator Meetings
* Report, write narratives and follow-up on serious adverse events
* Review progress of projects and initiate appropriate actions to achieve target objectives
* You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required
* Participate in the development of protocols and Case Report Forms as assigned
* Interact with internal work groups to evaluate needs, resources and timelines
Qualifications
* 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment
* Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas
* Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process
* Good planning, organization and problem solving abilities
* Good communication and interpersonal skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Sr. Clinical Trial Manager
Clinical Research Coordinator Job 15 miles from Denver
Research & Community Health Operations - Aurora, Colorado (Remote) We are looking for an experienced Sr. Clinical Trial Manager to join our team! Senior Clinical Trial Manager leads and serves as the primary point of contact for clinical trials site operations.
Remote candidates are welcome to apply.
In this position you will:
* Serve as the secondary contact to address site questions, when the site Clinical Research Associate (CRA) is unavailable.
* Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.
* Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.
* Proactively identify out of scope and notify the study Project Manager (PM).
* Work with head of Site Operations to ensure overall quality and project services, proactive issue resolution and development of systems to standardize and improve clinical trial management practices across all functional areas.
* Contribute to process improvement within Site Operations, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables.
* Participate in protocol development, risk assessment, database development, and clinical study report writing.
* Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.
* Develop site metrics based on the approved protocol and provide updates to the PM, as outlined in the study contract.
* Work with PM and Data Manager during the EDC build process in development of eCRFs, reports, and identification of variables required to support site management and monitoring activities.
* Assure proper maintenance of site required records for monitoring activities, Trial Master File maintenance, and required regulatory documents per CPC requirements.
* Develop study-specific monitoring visit reports and rubrics, follow-up letter templates, and project specific site materials including Monitoring Plans, Informed Consent Form (ICF) templates, Study Procedure Manual, source worksheets and site newsletter.
* Mentor CRAs and Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.
* Participate in project-related and other departmental/CPC meetings as required.
* Lead the Investigational Product (IP) release process and once IP release has occurred, work with the CRAs to collect all new or expiring Investigator regulatory documents.
* Participate in development of project specific training for CRAs and site staff and oversee training, as appropriate.
* Participate in development of site selection materials and oversee the selection of qualified sites and Investigators for participation in research protocols.
* Develop sites budgets and payment processes, including identification of EDC variables required to support site payments. Work with sites to negotiate the study site budget. Oversee tracking and payment process.
* Train CRAs at CPC and staff at selected research sites.
* Train and mentor Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, completing study site payments and creating project specific documents.
* Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.
* Work closely with other team members to ensure timely resolution of site issues.
* Conduct drug tracking and disposition as required by project.
* Participate in the development of remote monitoring. Oversee the remote monitoring.
* Conduct independent site, site co-monitoring, and CRA evaluation visits, as needed.
Here's what you will need to bring to the table:
* Nursing or bachelor's degree preferred.
* A minimum of 5 years of experience in clinical research setting required.
* Thorough knowledge and practice of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
* Thorough knowledge of the drug and device development process.
* Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).
* Experience with clinical trial management systems to include electronic data capture, randomization management, supply management systems.
* Excellent interpersonal communication skills, organizational skills and a great attention to detail.
* Ability to organize and instruct staff, while promoting group effort and achievement.
* Ability to lead multiple projects and operational tasks simultaneously.
* Ability to complete deliverables on time and within budget while maintaining quality.
* Ability to manage conflicts and resolve problems proactively, quickly and effectively.
* Ability to discern priorities with minimal direction to accomplish day-to-day tasks.
* Willingness to travel up to 25% of the time.
Targeted Compensation: $95,045 - $110,000 annually
Deadline to Apply: December 1, 2024
Note: Viable applicants will be required to pass a background and education verification check.
About CPC:
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy.
CPC offers:
* Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
* Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
* 11 paid holidays
* 15 - 25 vacation days based on years of service
* Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
* In-suite exercise and relaxation room
* Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
* Flexible and remote work schedules
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at ****************** .
-Select- Location
Aurora, Colorado (Remote)
Minimum Experience
Experienced
Compensation
$95,045 - $110,000
Research Project Coordinator
Clinical Research Coordinator Job In Denver, CO
Salary Estimate: $51396.80 - $74547.20 / year Learn more about the benefits offered for this job. The estimate displayed represents the typical salary range of candidates hired. Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role. The typical candidate is hired below midpoint of the range.
Introduction
The GME Research Project Coordinator will be responsible for coordinating multiple assigned scholarly activity and research project timelines throughout all lifecycle phases. The GME Research Project Coordinator will provide assistance in the development of scholarly activity and research related documents and will also work closely and effectively with physician principal investigator(s), resident(s), fellow(s), research directors, other members of the scholarly support team, and multiple internal clients.
Benefits
HealthOne, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:
* Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.
* Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.
* Free counseling services and resources for emotional, physical and financial wellbeing
* 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)
* Employee Stock Purchase Plan with 10% off HCA Healthcare stock
* Family support through fertility and family building benefits with Progyny and adoption assistance.
* Referral services for child, elder and pet care, home and auto repair, event planning and more
* Consumer discounts through Abenity and Consumer Discounts
* Retirement readiness, rollover assistance services and preferred banking partnerships
* Education assistance (tuition, student loan, certification support, dependent scholarships)
* Colleague recognition program
* Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence)
* Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.
Learn more about Employee Benefits
Note: Eligibility for benefits may vary by location.
Our teams are a committed, caring group of colleagues. Do you want to work as a(an) Research Project Coordinator where your passion for creating positive patient interactions is valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!
Job Summary and Qualifications
* Develop and maintain knowledge of scholarly activity pathways in GME and the health care environment.
* Contribute to the development of training, tools, and process documentation for both the department and for assigned projects
* Ability to think analytically and display effective brainstorming prowess and creativity, as well as work both autonomously and collaboratively with clients and colleagues required
* Demonstrate ability to create and deliver effective presentations
* Excellent written and verbal communication skills; must be able to communicate effectively with all levels
* Familiarity with Statistical Software (SPSS, STATA, R, or Python)
* Advanced skills in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, WebEx) required
* Ensure compliance to HCA data access policy and procedures
* The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required.
EDUCATION:
* Bachelor's Degree from an accredited program providing training in a research related field of study required, Master's Degree highly preferred
* Experience in health services research environment
* A minimum of one (1) year of project management (formal or informal) experience required; clinical experience preferred
* Preferred experience using Statistical Software (SPSS, STATA, R, Tableau or Python) or coursework in Biostatistics
Physician Services Group is skilled in physician employment, practice and urgent care operations. We are experts in hospitalist integration, and graduate medical education. We lead more than 1,300 physician practices and 170+ urgent care centers. We are HCA Healthcare's graduate medical education leader. We provide direction for over 260 exceptional resident and fellowship programs. We focus on carrying out value-added solutions. These solutions help physicians deliver patient-centered healthcare. We support HCA Healthcare's commitment to the care and improvement of human life.
HCA Healthcare has been recognized as one of the World's Most Ethical Companies by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.
"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Research Project Coordinator opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Trial Associate
Clinical Research Coordinator Job In Denver, CO
LEWIS & ASSOCIATES
is a leader in providing Legal and Administrative staffing services. We are a sole source staffing firm giving you convenient ways of working with us. We make every effort to ensure the highest degree of professionalism and integrity in the staffing process. We understand the demanding role of recruiting to source the highest level of legal professionals while incorporating proven, innovative, and successful recruiting techniques.
Job Description
Our client is seeking a litigation associate with two to four years of experience to join the Trial Department in its Denver office. This associate will work in all phases of commercial litigation, with an emphasis on intellectual property litigation, from pleading through trial and appeal. This associate will have the opportunity to take depositions, appear in court, and work closely with partners.
Strong academic performance, excellent writing skills, and two to four years of litigation experience are required. Specifically, we are seeking someone who has experience beyond document review and has handled significant parts of active cases. Admission to the Colorado bar is a plus.
Additional Information
Only candidates that meet the requirements will be contacted.
Clinical Research Coordinator, Denver, CO
Clinical Research Coordinator Job In Denver, CO
3040-Research - LMG - Clinical Research Coordinator
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.
Assists the PI in study feasibility assessments as requested.
Reviews and comprehends the protocol.
Attends investigator meetings as required or requested by the PI.
Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.
Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs and temperature logs.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Develop advertising and other informational materials to be used in subject recruitment.
Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol. Prepares the specimens for shipping to laboratory.
Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos. Assures timely completion of Case Report Forms.
Maintains study timelines.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. Dispenses study drug to study patients.
Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, and note to file, case report forms, and investigational material accountability forms.
Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
Retains all study records in accordance with sponsor requirements in Regulatory binder
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and policies and procedures.
Arranges secure storage of study documents that will be maintained according to the contracted length of time, whichever is longer.
KNOWLEDGE, SKILLS, AND ABILITIES
Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties
Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned
Ability to practice confidentiality and follow HIPAA regulations with patient information
Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization
Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary
Knowledge of medical terminology and ability to use appropriately
Ability to manage time efficiently, prioritize, multi-task, and adapt to change
Ability to maintain high level of accuracy in all documentation and in the performance of all job duties
Ability to perform the essential job duties within the scope of education and training
Skilled in typing/keyboarding; skilled in using computers
PROFESSIONALISM
Project a professional manner and image, including proper workplace attire and grooming standards; exhibit professional conduct at all times.
Adhere to ethical principles and core ADCS values; follow all ADCS policies
Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity
Demonstrate initiative and responsibility for actions
Work as an effective team member
Maintain a strong record for attendance and punctuality in arriving at work
Enhance skills through continuing education
EDUCATION
Bachelor's degree in a related field preferred but not required
LICENSURE/CERTIFICATION REQUIREMENTS
Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP
Good Clinical Practice (GCP) preferred
International Air Transport Association (IATA) Training preferred
LANGUAGE/COMMUNICATION REQUIREMENTS
Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence
Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding
Ability to practice professional telephone etiquette and techniques on all calls
MATHEMATICAL SKILLS
The ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
REASONING ABILITY
Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
WORK ENVIRONMENT AND CONDITIONS
Work is performed in offices and occasionally research sites. Involves frequent telephone and in-person contact with staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work required. Occasional travel required.
COMPENSATION
-401K/PTO/Vacation/Benefit Packages
NOTE: This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.
Other details
Pay Type Hourly
Min Hiring Rate $24.00
Max Hiring Rate $30.00
Veterinary Clinical Research Specialist - CHIRP (Must have experience in Animal Sciences)
Clinical Research Coordinator Job 22 miles from Denver
**Veterinary Clinical Research Specialist - CHIRP (Must have experience in Animal Sciences)** * Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
* Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact ******************************** . If you have questions while submitting an application, please review these .
****Current Employees and Students:****
**If you are currently employed or enrolled as a student at The Ohio State University, please l og in to Workday to use the internal application process.**
**Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:**
**Job Title:**
Veterinary Clinical Research Specialist - CHIRP (Must have experience in Animal Sciences)**Department:**
Veterinary Medicine | Veterinary Clinical SciencesThe Comparative Hepatobiliary and Intestinal Research Program (CHIRP) is comprised of a team of basic research and clinician scientists (J. Winston, A. Rudinsky, V. Parker, and M. Schreeg) at the forefront of cutting-edge research and innovative study design. CHIRP was developed to streamline multidisciplinary research with a specific focus on team science. The axis of our program centers on the advancement of knowledge pertaining to gastrointestinal, hepatobiliary, and pancreatic diseases in dogs and cats coupled with dedicated enhancement of animal and human health through translational scientific discoveries. CHIRP's mission is to **advance collaborative research at the interface of animal and human health.**
****Position Duties:****
The successful candidate will report to the Comparative Hepatobiliary and Intestinal Research Program (CHIRP) director (J. Winston) and will work in our collaborative team that includes CHIRP faculty, post-doctoral scholars, graduate students, residents, and veterinary students. The candidate will maintain and manage the CHIRP laboratory while also participating and providing support to ongoing CHIRP research including veterinary clinical trials and murine model experiments. Specific duties include, but are not limited to:
****Laboratory/CHIRP Maintenance Duties****
* Provides work training for support staff and student researchers
* Assist/supervise student researchers in the cleaning and sanitation of the lab
* Work with central supply/Goss for autoclave/sterilization processing
* Processes, sorts, measures, labels, and ships samples and specimens on an as needed basis
* Processes and monitors laboratory billing/clinical write offs
* Maintains lab and project logs/diaries
* Manage discard/waste syringes, vials, containers, biosamples in appropriate containers with EHS
* Unpack deliveries, reconcile against packing slip, restock supplies
* Maintain laboratory equipment
* Maintain laboratory protocols/policies/approvals with EHS
* Maintains laboratory chemical inventory
* Order/manage inventory/supplies
****Laboratory Science Duties****
* Processing feces and microbial samples for molecular techniques (e.g. DNA extractions)
* Biobanking of basic clinical samples - serum, feces, urine, histopathology
* Identify bacteria, parasites, and other microorganisms using parasitology and microbiology techniques
* Microbiology, chemical, and/or bacteriological testing of organisms
* Performs PCR and qPCR
* +/- Flow Cytometry Understanding
* +/- Electrophoresis/Western Blotting
* +/- IHC and Microscopy
****Veterinary Clinical Trials and Animal Model Experimental Duties****
* Animal handling - dogs, cats, mice
* Assist with experimental set-up and execution (including autoclaving, sample labeling, sample acquisition/necropsy, and sample processing)
* Manage clinical appointments
* Assist in the implementation of research projects
* Assist with the recruitment of research participants and obtaining informed consent forms
* Compiles and enters research data (including in databases such as REDCAP)
* Writes reports and presents data based on findings from experiments conducted for assigned projects
* Conduct literature searches, and maintains an up-to-date knowledge of all current methods of experimentation
****Required Qualifications:****
**Bachelor's degree in a relevant biology, zoology, microbiology, and or animal science area or an equivalent combination of education and experience; minimum of two years of experience in animal handling; superb communications skills and well-developed interpersonal skills.**
****Desired Qualifications:****
**MS degree and/or PhD in relevant biology, zoology, microbiology, and or animal science area; Two to four years of experience working in a basic science laboratory; excellent attention to detail and organization skills; public speaking and presentation competence; manuscript and grant writing experience.**
****Additional Information:****
This is a ****term**** position (minimum of one year and maximum of four years). The actual term of the position is dependent upon performance and CHIRP Shared Resource budget.
**Additional Information:**
**Must have a minimum of two years of experience in animal handling.**
**Target Salary Range: $22.69 - $29.83 per hour**
**Location:**
Veterinary Medical Center (0299)**Position Type:**
Term (Fixed Term)**Scheduled Hours:**
40****Shift:****
First Shift***Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.***
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the .
The Ohio State University is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability, ethnicity, gender identity or expression, genetic information, HIV/AIDS status, military status, national origin, race, religion, sex, gender, sexual orientation, pregnancy, protected veteran status, or any other basis under the law.
Applicants are encouraged to complete and submit the Equal Employment Identification form.
**Each day, Buckeyes across the state and around the world make a lasting impact.**
The Ohio State University sets the stage for academic achievement and innovation. It's where friendships are forged, tradition is brought to life and a better global community is built. Our mission is as clear today as it was 150 years ago: to illuminate a pathway to education, research and health care that creates vibrant futures.
Faculty and staff build the incomparable Buckeye spirit through collaboration, a strong sense of community and an unwavering commitment to excellence. Our strength comes from our ability to bring out the best in people and learn from Buckeyes of all backgrounds, passions and talents.
Ohio State is a dynamic community where opportunity thrives and individuals transform themselves and their world. Positions are available in countless fields and specialties.
Ohio State is a top-20 public university, and its Ohio State Wexner Medical Center is one of America's leading academic health centers and recently ranked No. 4 on Forbes' list of best U.S. employers for diversity.
Eligible Ohio State employees receive comprehensive benefits
Research Coordinator, Department of Psychology
Clinical Research Coordinator Job In Denver, CO
The Department of Psychology at the University of Denver is a highly collaborative, research-oriented department that values interdisciplinary perspectives (see ********************* for more information). The University of Denver is guided by a vision to be a great private university dedicated to the public good. DU values inclusive excellence, recognizing that its success is dependent on how well it values, engages and includes the rich diversity of constituents (to learn more, please visit ********************************** Students and faculty in the Psychology Department actively contribute to these goals through scholarship, teaching, and service. DU is situated in the Denver metro area, a vibrant and diverse urban center in the Rocky Mountain region that is home to nearly 2.6 million people. DUs urban location supports faculty collaboration across a number of local universities. DU is comprised of approximately 5000 undergraduates, 6500 graduate students, and more than 600 full-time faculty.
Position Summary
The position will be shared between the labs of Dr. Kateri McRae (the Automaticity, Affect, Control, and Thought [AACT] Lab; **************************************** and Dr. Kimberly Chiew (the Motivation, Affect, & Cognition [MAC] Lab; ***************** at the University of Denver. The AACT lab conducts research regarding emotion-cognition interactions, often studying emotion regulation, such as the emotion regulation technique of cognitive reappraisal, using questionnaires, self-reported emotion in laboratory tasks, psychophysiology, and neuroimaging (fMRI). The MAC Lab also studies emotion-cognition interactions, with particular interest in characterizing emotional and motivational influences on cognitive control and memory, using questionnaires, behavioral paradigms, psychophysiological, and neural measures (including fMRI and TMS). The main purpose of this position is to provide research and logistical support to both labs by assisting at a high level in research projects. This will include collecting and analyzing data using behavioral and biological techniques (including physiological and neuroimaging data collection), managing and analyzing datasets, and recruiting and screening study participants remotely and in person. The ideal applicant should enjoy problem-solving, organization, and the implementation of efficient, long-term solutions. As this position is shared between two labs, applicants should be comfortable managing multiple simultaneous projects and competing priorities to effectively complete tasks in a timely manner. This is a full-time position that comes with DU's full benefits package. The schedule requires the ability to generally work business hours (some outside hours may be required) primarily in-person. During data collection, some afternoon evening/weekend in-person availability will likely be required. Initial contract will be for one year, with additional years possible pending mutual agreement. This position is ideal for candidates with interests in applying to graduate school in the future, although the depth or breadth of this involvement will be in accordance with the employees long-term career goals and abilities. This is a grant funded position with a minimum one-year appointment. Continuation is based on continued need, funding and satisfactory performance.
Essential Functions
Coordinating, overseeing, and assisting with data collection, administering laboratory tasks in-person and remotely using computerized platforms to characterize cognitive and emotional measures and behavior, and psychosocial assessments (e.g., questionnaires and interviews).
In-person data collection will be conducted primarily with adult participants, and may include participant recruitment, physiological assessments (e.g., skin conductance, heart rate and blood pressure), and neuroimaging and neurostimulation data collection (fMRI/TMS) at University of Colorado facilities (training will be provided in these data modalities).
Additional duties include:
Managing undergraduate research assistants.
Overseeing lab facilities including Mac and PC workstations, installing software, setting up hardware, and troubleshooting computer-related issues.
Gathering, organizing and maintaining centralized laboratory information, including lab websites; and assisting with IRB, training, and financial management.
Applicants should have prior experience conducting psychological research, including in participant recruitment, data collection, data storage, and basic data analysis to provide support for these activities and to independently perform them. The research coordinator will also be expected to develop reliable practices for behavioral and psychophysiological data analysis (including some coding or modification of existing scripts), and support other members of the lab in implementing these practices. Experience coding (especially with MATLAB, R, and/or Python) is ideal, but not required. The ideal applicant should enjoy problem-solving, organization, and the implementation of efficient, long-term solutions. As this position is shared between two labs, applicants should be comfortable managing multiple simultaneous projects to effectively complete tasks in a timely manner. In addition, the research coordinator will have the opportunity to substantially contribute to new research projects. The depth or breadth of this involvement will be in accordance with the employees long-term career goals and abilities.
Knowledge, Skills, and Abilities
Fluency in English.
Attention to detail and organizational skills.
Basic statistical knowledge required related to managing data; ability to perform basic statistical analyses.
Familiarity with coding or scripting to automate data management and analysis procedures.
Excellent reasoning ability, both in the abstract (e.g. managing multiple goals & responsibilities) and the concrete (e.g. prioritizing multiple simultaneous tasks and managing time independently).
Experience with remote meeting technology and good digital communication skills; ability to manage projects and people who are working in person and remotely.
Good interpersonal skills; readiness to work with others as part of a research team, help fix technological or scheduling issues.
Tolerance for being interrupted while working to deal with an immediate issue.
Willingness to travel to University of Colorado-Boulder and Anschutz Medical Campus for data collection at fMRI and TMS facilities.
Required Qualifications
B.A. or B.S. degree.
Experience with Mac and PC systems.
Experience conducting and assisting with psychological or medical research projects.
Preferred Qualifications
B.A. or B.S. degree with major focus in Psychology, Neuroscience, or other health fields.
Excellent GPA.
Excellent interpersonal and managerial skills.
Advanced statistical knowledge.
Advanced coding or scripting experience, especially for in statistical analysis applications.
Familiarity with BIOPAC & AcqKnowledge physiological hardware and software.
Experience managing or analyzing functional neuroimaging data.
Desire to implement long-lasting organizational systems.
Excitement to work with, teach, and learn from others in the laboratories.
Work Schedule
Monday - Friday, 8:00 a.m. - 4:30 p.m.
Application Deadline
For best consideration, please submit your application materials by 4:00 p.m. (MST) on Thursday, July 15th, 2021.
Special Instructions
Candidates must apply online through jobs.du.edu to be considered. Only applications submitted online will be accepted.
Salary Grade Number
The salary grade for the position is 4.
Hourly Range
The hourly range for the position is $17.00 - $19.00.
The University of Denver has provided a compensation range that represents its good faith estimate of what the University may pay for the position at the time of posting. The University may ultimately pay more or less than the posted compensation range. The salary offered to the selected candidate will be determined based on factors such as the qualifications of the selected candidate, departmental budget availability, internal salary equity considerations, and available market information, but not based on a candidate's sex or any other protected status.
Benefits
The University of Denver offers excellent benefits, including medical, dental, retirement, paid time off, tuition benefit and ECO pass. The University of Denver is a private institution that empowers students who want to make a difference. Learn more about the University of Denver.
Please include the following documents with your application:
1. Resume
2. Cover Letter
The University of Denver is committed to enhancing the diversity of its faculty and staff. We are an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity, disability, military/ veteran status or any other status protected by law.
All offers of employment are based upon satisfactory completion of a criminal history background check.
DVOMB Clinical Contractor
Clinical Research Coordinator Job 22 miles from Denver
Interested in mental health therapy? Looking to gain addiction counseling experience? Whether you are interested in therapy, treatment, behavioral health, psychology, social work, counseling, criminal justice, or restorative justice, we have a position for you!
The mission of Behavioral Treatment Services is to provide accessible, integrated, and inclusive behavioral health services supporting clients throughout the criminal justice system. Behavioral Treatment Services provides a continuum of specialized adult offender substance abuse and other treatment modalities. Being a part of the BTS team means being a part of the forefront of Colorado's behavioral health and criminal justice programs and initiatives. Our goals are to provide a space toward client healing, reduce criminal recidivism, assist clients in working towards personal growth, and collaborate with the system and client to work towards mutually agreeable goals.
BTS provides clinical services, court related services, and specialized programs for adults involved in the criminal justice system. BTS provides services at community corrections sites (including residential treatment programs), outpatient locations, jail based, and court liaison programs in 9 counties across Colorado.
Title: DVOMB Clinical Contractor
Location: Boulder, CO
Hours: Contract: Flexible schedule available
Salary: This is a contract position that does not include paid benefits or leave options. This contract will pay:
$175 per group (including documentation)
$65 per hour for intakes/assessments
$30 for a 30-minute individual session (including documentation)
$65 for a 60-minute individual session (including documentation)
$40 per administrative hour.
Summary: The candidate will facilitate domestic violence treatment groups in our Boulder BTS location three times per week for a minimum of 120 minutes per day, with 12 or fewer male clients in each group.
Essential Duties and Responsibilities:
Offender evaluation, assessment, creation of a treatment plan, and offender contract.
Facilitation of domestic violence treatment (levels A, B, and C), according to the DVOMB standards.
Cooperation with the MTT and collateral agencies.
Providing victim advocacy.
Documentation of all interactions, progress notes, evaluations, assessments, violations, and discharges
Treat all clients with dignity and respect;
Observe confidentiality requirements;
Functions in accordance with the professions Code of Ethics and Facility's policies and procedures;
Work Traits:
Controls problem situations in a calm and directive manner;
Demonstrates personal & professional growth on an ongoing basis;
Demonstrates competency in accordance with the 12 core counseling functions defined by the National Association of Alcohol and Drug Abuse Counselors.
Minimum Qualifications:
Master's degree in social work, psychology, counseling, or related field;
Active registration in DORA;
Colorado DVOMB Certified
Approved Full Operating Level Provider LPC, LCSW, LMFT
Preferred Qualifications:
Experience working in a substance abuse treatment program with a diverse population;
Experience providing substance abuse treatment to adult offenders;
Familiar with evidence-based treatment models;
Excellent communications and interpersonal skills;
Bilingual in English and Spanish a plus
Learn more about us by going to *********************
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Application Deadline: Open until filled
Veterinary Clinical Research Specialist - CHIRP (Must have experience in Animal Sciences)
Clinical Research Coordinator Job 22 miles from Denver
**Veterinary Clinical Research Specialist - CHIRP (Must have experience in Animal Sciences)** * Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
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****Current Employees and Students:****
**If you are currently employed or enrolled as a student at The Ohio State University, please l og in to Workday to use the internal application process.**
**Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:**
**Job Title:**
Veterinary Clinical Research Specialist - CHIRP (Must have experience in Animal Sciences)**Department:**
Veterinary Medicine | Veterinary Clinical SciencesThe Comparative Hepatobiliary and Intestinal Research Program (CHIRP) is comprised of a team of basic research and clinician scientists (J. Winston, A. Rudinsky, V. Parker, and M. Schreeg) at the forefront of cutting-edge research and innovative study design. CHIRP was developed to streamline multidisciplinary research with a specific focus on team science. The axis of our program centers on the advancement of knowledge pertaining to gastrointestinal, hepatobiliary, and pancreatic diseases in dogs and cats coupled with dedicated enhancement of animal and human health through translational scientific discoveries. CHIRP's mission is to **advance collaborative research at the interface of animal and human health.**
****Position Duties:****
The successful candidate will report to the Comparative Hepatobiliary and Intestinal Research Program (CHIRP) director (J. Winston) and will work in our collaborative team that includes CHIRP faculty, post-doctoral scholars, graduate students, residents, and veterinary students. The candidate will maintain and manage the CHIRP laboratory while also participating and providing support to ongoing CHIRP research including veterinary clinical trials and murine model experiments. Specific duties include, but are not limited to:
****Laboratory/CHIRP Maintenance Duties****
* Provides work training for support staff and student researchers
* Assist/supervise student researchers in the cleaning and sanitation of the lab
* Work with central supply/Goss for autoclave/sterilization processing
* Processes, sorts, measures, labels, and ships samples and specimens on an as needed basis
* Processes and monitors laboratory billing/clinical write offs
* Maintains lab and project logs/diaries
* Manage discard/waste syringes, vials, containers, biosamples in appropriate containers with EHS
* Unpack deliveries, reconcile against packing slip, restock supplies
* Maintain laboratory equipment
* Maintain laboratory protocols/policies/approvals with EHS
* Maintains laboratory chemical inventory
* Order/manage inventory/supplies
****Laboratory Science Duties****
* Processing feces and microbial samples for molecular techniques (e.g. DNA extractions)
* Biobanking of basic clinical samples - serum, feces, urine, histopathology
* Identify bacteria, parasites, and other microorganisms using parasitology and microbiology techniques
* Microbiology, chemical, and/or bacteriological testing of organisms
* Performs PCR and qPCR
* +/- Flow Cytometry Understanding
* +/- Electrophoresis/Western Blotting
* +/- IHC and Microscopy
****Veterinary Clinical Trials and Animal Model Experimental Duties****
* Animal handling - dogs, cats, mice
* Assist with experimental set-up and execution (including autoclaving, sample labeling, sample acquisition/necropsy, and sample processing)
* Manage clinical appointments
* Assist in the implementation of research projects
* Assist with the recruitment of research participants and obtaining informed consent forms
* Compiles and enters research data (including in databases such as REDCAP)
* Writes reports and presents data based on findings from experiments conducted for assigned projects
* Conduct literature searches, and maintains an up-to-date knowledge of all current methods of experimentation
****Required Qualifications:****
**Bachelor's degree in a relevant biology, zoology, microbiology, and or animal science area or an equivalent combination of education and experience; minimum of two years of experience in animal handling; superb communications skills and well-developed interpersonal skills.**
****Desired Qualifications:****
**MS degree and/or PhD in relevant biology, zoology, microbiology, and or animal science area; Two to four years of experience working in a basic science laboratory; excellent attention to detail and organization skills; public speaking and presentation competence; manuscript and grant writing experience.**
****Additional Information:****
This is a ****term**** position (minimum of one year and maximum of four years). The actual term of the position is dependent upon performance and CHIRP Shared Resource budget.
**Additional Information:**
**Must have a minimum of two years of experience in animal handling.**
**Target Salary Range: $22.69 - $29.83 per hour**
**Location:**
Veterinary Medical Center (0299)**Position Type:**
Term (Fixed Term)**Scheduled Hours:**
40****Shift:****
First Shift***Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.***
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**Each day, Buckeyes across the state and around the world make a lasting impact.**
The Ohio State University sets the stage for academic achievement and innovation. It's where friendships are forged, tradition is brought to life and a better global community is built. Our mission is as clear today as it was 150 years ago: to illuminate a pathway to education, research and health care that creates vibrant futures.
Faculty and staff build the incomparable Buckeye spirit through collaboration, a strong sense of community and an unwavering commitment to excellence. Our strength comes from our ability to bring out the best in people and learn from Buckeyes of all backgrounds, passions and talents.
Ohio State is a dynamic community where opportunity thrives and individuals transform themselves and their world. Positions are available in countless fields and specialties.
Ohio State is a top-20 public university, and its Ohio State Wexner Medical Center is one of America's leading academic health centers and recently ranked No. 4 on Forbes' list of best U.S. employers for diversity.
Eligible Ohio State employees receive comprehensive benefits
Clinical Research Coordinator, Denver, CO
Clinical Research Coordinator Job In Denver, CO
3040-Research - LMG - Clinical Research Coordinator The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.
* Assists the PI in study feasibility assessments as requested.
* Reviews and comprehends the protocol.
* Attends investigator meetings as required or requested by the PI.
* Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.
* Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs and temperature logs.
* Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
* Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
* Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
* Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
* Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
* Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
* Develop advertising and other informational materials to be used in subject recruitment.
* Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.
* Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
* Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol. Prepares the specimens for shipping to laboratory.
* Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos. Assures timely completion of Case Report Forms.
* Maintains study timelines.
* Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. Dispenses study drug to study patients.
* Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, and note to file, case report forms, and investigational material accountability forms.
* Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
* Retains all study records in accordance with sponsor requirements in Regulatory binder
* Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
* Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and policies and procedures.
* Arranges secure storage of study documents that will be maintained according to the contracted length of time, whichever is longer.
KNOWLEDGE, SKILLS, AND ABILITIES
* Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties
* Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned
* Ability to practice confidentiality and follow HIPAA regulations with patient information
* Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization
* Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary
* Knowledge of medical terminology and ability to use appropriately
* Ability to manage time efficiently, prioritize, multi-task, and adapt to change
* Ability to maintain high level of accuracy in all documentation and in the performance of all job duties
* Ability to perform the essential job duties within the scope of education and training
* Skilled in typing/keyboarding; skilled in using computers
PROFESSIONALISM
* Project a professional manner and image, including proper workplace attire and grooming standards; exhibit professional conduct at all times.
* Adhere to ethical principles and core ADCS values; follow all ADCS policies
* Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity
* Demonstrate initiative and responsibility for actions
* Work as an effective team member
* Maintain a strong record for attendance and punctuality in arriving at work
* Enhance skills through continuing education
EDUCATION
Bachelor's degree in a related field preferred but not required
LICENSURE/CERTIFICATION REQUIREMENTS
* Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP
* Good Clinical Practice (GCP) preferred
* International Air Transport Association (IATA) Training preferred
LANGUAGE/COMMUNICATION REQUIREMENTS
* Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals
* Ability to write routine reports and correspondence
* Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding
* Ability to practice professional telephone etiquette and techniques on all calls
MATHEMATICAL SKILLS
The ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
REASONING ABILITY
Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
WORK ENVIRONMENT AND CONDITIONS
Work is performed in offices and occasionally research sites. Involves frequent telephone and in-person contact with staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work required. Occasional travel required.
COMPENSATION
* 401K/PTO/Vacation/Benefit Packages
NOTE: This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.
Other details
* Pay Type Hourly
* Min Hiring Rate $24.00
* Max Hiring Rate $30.00
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* 3540 S Poplar St, Denver, CO 80237, USA