Clinical Coordinator-Cath Lab
Clinical research associate job in Joplin, MO
Find your calling at Mercy!The Clinical Coordinator is responsible for professional cardiac care for patients and their families by direction, supervision and example. Provides direction to Registered Nurses, Radiology Technologist, students and non-professional nursing personnel in providing direct patient care. Responsible for clinical operation of the Cath Lab on a shift by shift basis ensuring that all regulatory requirements and standards are being fulfilled. Participates in the education and development of Cardiology personnel and performance evaluation as well as other administrative duties as designated by the Director of CV Services. Must have strong interpersonal skills, the ability to manage multiple priorities, be dedicated to the provision of quality patient care and use sound judgment in decision making. Performs duties and responsibilities in a manner consistent with our mission, values, and Mercy Service Standards.Position Details:
Education: Graduate of an accredited school of nursing. ADN required, BSN preferred (RN) or graduation from an AMA approved school of Radiologic Technology, either college-affiliated or hospital-trained (Cath Lab Tech).
Licensure: Registered Nurse in the applicable state of practice or compact state with a license in good standing or ARRT and a Rad Tech License in the applicable state of practice.
Experience: 3-5 years cath lab experience is preferred.
Certification/Registration: CPR, ACLS, RCIS
Other skills & knowledge (skills, knowledge, abilities): Ability to read and communicate effectively in English. Additional languages preferred. Basic computer knowledge. Organizing and coordinating skills. Knowledge of accreditation and certification requirements and standards. Strong interpersonal skills and the ability to effectively work with a wide range of individuals and constituencies in a diverse community. Advanced assessment skills.
Why Mercy?
From day one, Mercy offers outstanding benefits - including medical, dental, and vision coverage, paid time off, tuition support, and matched retirement plans for team members working 32+ hours per pay period.
Join a caring, collaborative team where your voice matters. At Mercy, you'll help shape the future of healthcare through innovation, technology, and compassion. As we grow, you'll grow with us.
Clinical Coordinator-Cath Lab
Clinical research associate job in Joplin, MO
Find your calling at Mercy!The Clinical Coordinator is responsible for professional cardiac care for patients and their families by direction, supervision and example. Provides direction to Registered Nurses, Radiology Technologist, students and non-professional nursing personnel in providing direct patient care. Responsible for clinical operation of the Cath Lab on a shift by shift basis ensuring that all regulatory requirements and standards are being fulfilled. Participates in the education and development of Cardiology personnel and performance evaluation as well as other administrative duties as designated by the Director of CV Services. Must have strong interpersonal skills, the ability to manage multiple priorities, be dedicated to the provision of quality patient care and use sound judgment in decision making. Performs duties and responsibilities in a manner consistent with our mission, values, and Mercy Service Standards.Position Details:
Education: Graduate of an accredited school of nursing. ADN required, BSN preferred (RN) or graduation from an AMA approved school of Radiologic Technology, either college-affiliated or hospital-trained (Cath Lab Tech).
Licensure: Registered Nurse in the applicable state of practice or compact state with a license in good standing or ARRT and a Rad Tech License in the applicable state of practice.
Experience: 3-5 years cath lab experience is preferred.
Certification/Registration: CPR, ACLS, RCIS
Other skills & knowledge (skills, knowledge, abilities): Ability to read and communicate effectively in English. Additional languages preferred. Basic computer knowledge. Organizing and coordinating skills. Knowledge of accreditation and certification requirements and standards. Strong interpersonal skills and the ability to effectively work with a wide range of individuals and constituencies in a diverse community. Advanced assessment skills.
Why Mercy?
From day one, Mercy offers outstanding benefits - including medical, dental, and vision coverage, paid time off, tuition support, and matched retirement plans for team members working 32+ hours per pay period.
Join a caring, collaborative team where your voice matters. At Mercy, you'll help shape the future of healthcare through innovation, technology, and compassion. As we grow, you'll grow with us.
Clinical Research Associate - East/Central
Clinical research associate job in Lenexa, KS
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
**What you will be doing**
+ Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
+ Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
+ Collaborating with investigators and site staff to facilitate smooth study conduct.
+ Performing data review and resolution of queries to maintain high-quality clinical data.
+ Contributing to the preparation and review of study documentation, including protocols and clinical study reports
**Your profile**
+ Bachelor's degree in a scientific or healthcare-related field.
+ Minimum of 2 years of experience as a Clinical Research Associate.
+ In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
+ Strong organizational and communication skills, with attention to detail.
+ Ability to work independently and collaboratively in a fast-paced environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (******************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (****************************************************** to apply
Sr. Clinical Research Associate - Oncology - Southeast Region - FSP
Clinical research associate job in Topeka, KS
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#LI-LO1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Research Associate 1
Clinical research associate job in Minneapolis, KS
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Trial Master File (TMF) Specialist Oncology
Clinical research associate job in Topeka, KS
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, 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.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
**Key Responsibilities**
+ Responsible for overall quality, maintenance, and completeness of Trial Master Files.
+ Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
+ Develop project specific TMF plan and structure and update the plan as needed.
+ Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
+ Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
+ Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
+ Provide study team reports or updates regarding status of TMF on a regular basis.
+ Participate in audits and provide documents as requested.
+ Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
+ Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
+ Champion best practices for building and maintaining TMF health.
**Professional Experience / Qualifications**
+ BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
+ Knowledge of and direct experience with Trial Master Files.
+ Prior eTMF (e.g. Veeva) administration required.
+ Strong Microsoft Office skills required.
+ Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
+ Fundamental knowledge of the conduct of clinical trials is preferred.
+ Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
The base salary range for this role is $72,500 to $90,600. 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 flexible 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**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) employer**
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; 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.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, 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.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
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 Study Coordinator-JCCT
Clinical research associate job in Lenexa, KS
Study Coordinator
Department: Study Management
Purpose:
The Study Coordinator is responsible for the coordination and administration of clinical studies under the direction of the Director of Study Management, and the Medical Director/Principal Investigator.
Position Summary:
This position will develop, implement and coordinate research and administrative procedures for the successful management of clinical studies. The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. This position will report directly to the Clinical Study Team Manager.
Key Responsibilities (Essential Functions):
Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
Communicate with Nursing staff on an ongoing basis regarding study updates, amendments/ changes.
Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
Professional communication and collaborative work ethic with CRAs at Site visits.
Order and track supplies or devices necessary for study completion.
Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
Track enrollment status of volunteers and documentation in Clinical Conductor system.
Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
Adherent to safety and privacy regulations
Other duties as assigned
Education and Work Experience:
High school diploma or GED is required; Bachelor's degree in Science is preferred
3 to 5 years of experience in a clinical research setting or related work environment is preferred
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
Familiarity with or ability to learn clinical trial management system software
Skills and Competencies:
Excellent communication, interpersonal, analytical and problem-solving skills Microsoft Office Suite proficiency
Writing and verbal communication skills
Strong study documentation skills in compliance with ALCOA+
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc.
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Ability to prioritize and manage multiple projects simultaneously
Memory to retain information and know where to research answers
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong critical thinking, problem solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadline
Physical Requirements:
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds
Why JCCT?
JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.
We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.
Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.
If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!
EEO
JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Salary Description $28-$36 /Hour
Senior Clinical Research Coordinator
Clinical research associate job in Saint Louis, MO
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
In the performance of their respective tasks and duties all employees are expected to conform to the following:
Perform quality work within deadlines with or without direct supervision.
Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments.
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.
Position purpose
The Senior Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities/Duties/Functions/Tasks:
Communicate study requirements to all individuals involved in the study.
Develop and implement recruitment strategies in accordance with Impact Research and IRB requirements and approvals.
Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.
Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding source.
Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or Impact ResearchPolicy on Investigational Drug/Device Accountability.
Complete study documentation and maintenance of study files in accordance with sponsor requirements and Impact Research policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study.
Manage the day to day activities of the study including problem solving, communication and protocol management.
Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI.
Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with Impact Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
Other duties as assigned.
Qualifications
Education: High school diploma/GED certificate required. Associates degree from an accredited university preferred.
Experience: Minimum 4 or more years of clinical research experience.
Other Requirements: CRC certification preferred.
Performance Requirements:
Knowledge of grammar, spelling, and punctuation.
Knowledge of purchasing, budgeting, and inventory control.
Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions.
Skill in time management, prioritization, and multitasking.
Skill in writing and communicating effectively.
Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures.
Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.
Must be able to lift up to 25 lbs.
Must be able to travel and MVR
Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work.
Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Auto-ApplyClinical Research Study Assistant II - Neurology
Clinical research associate job in Saint Louis, MO
Scheduled Hours 40 Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data.
Job Description
Primary Duties & Responsibilities:
* Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants.
* Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed.
* Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary.
* Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information.
* Performs other duties as assigned.
Working Conditions:
Job Location/Working Conditions:
* Normal office environment.
Physical Effort:
* Typically sitting at desk or table.
* Repetitive wrist, hand or finger movement.
Equipment:
* Office equipment.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.
Required Qualifications
Education:
High school diploma or equivalent high school certification or combination of education and/or experience.
Certifications:
The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.
Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Work Experience:
Administrative Or Research (2 Years)
Skills:
Not Applicable
Driver's License:
A driver's license is not required for this position.
More About This Job
Required Qualifications:
* Basic Life Support certification must be obtained within one month of hire date
* Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements).
Preferred Qualifications
Education:
Associate degree
Certifications:
No additional certification unless stated elsewhere in the job posting.
Work Experience:
No additional work experience unless stated elsewhere in the job posting.
Skills:
Interpersonal Communication, Oral Communications, Organizing, Written Communication
Grade
C07-H
Salary Range
$19.21 - $28.85 / Hourly
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.
Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Benefits Statement
Personal
* Up to 22 days of vacation, 10 recognized holidays, and sick time.
* Competitive health insurance packages with priority appointments and lower copays/coinsurance.
* Take advantage of our free Metro transit U-Pass for eligible employees.
* WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
* Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
* We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered.
* WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: ******************************
EEO Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
Auto-ApplyHospice Clinical Coordinator
Clinical research associate job in Topeka, KS
At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place.
:
Clinical Coordinator
At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers.
To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today!
Why Join the Elara Caring mission?
Work in a collaborative environment.
Be rewarded with a unique opportunity to make a difference
Competitive compensation package
Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost
Opportunities for advancement
Comprehensive insurance plans for medical, dental, and vision benefits
401(K) with employer match
Paid time off, paid holidays, family, and pet bereavement
Pet insurance
As Clinical Coordinator, you'll contribute to our success in the following ways:
Builds teams to offer the highest quality of life to our patients.
Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered.
Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity.
Assists staff in maintaining current and accurate medical records and utilization review.
Assists clinical supervisor with non-clinical phone inquiries.
Notifies supervisor of any problems requiring administrative attention and intervention.
Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment.
Implements all available actions to prevent avoidable hospitalization and ER visits.
Attends training, education, seminars, or other means of learning.
Treats patients and caregivers in the highest and most effective manner.
Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel.
Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care.
Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule.
Performs other duties/projects as assigned.
What is Required?
1+ year experience in a hospice or home health care setting
Proficiency with Medical Terminology
Experience working with clinical management team
Proficiency with office equipment including computer, fax, copy machines
Experience with Medicare and Medicaid guidelines are preferred
You will report to the Clinical Manager.
This is not a comprehensive list of all job
responsibilities
; a full
will be provided.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families.
Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law.
Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9.
At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location.
This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided.
If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
Auto-ApplyHospice Clinical Coordinator
Clinical research associate job in Lawrence, KS
At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place.
:
Clinical Coordinator
At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers.
To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today!
Why Join the Elara Caring mission?
* Work in a collaborative environment.
* Be rewarded with a unique opportunity to make a difference
* Competitive compensation package
* Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost
* Opportunities for advancement
* Comprehensive insurance plans for medical, dental, and vision benefits
* 401(K) with employer match
* Paid time off, paid holidays, family, and pet bereavement
* Pet insurance
As Clinical Coordinator, you'll contribute to our success in the following ways:
* Builds teams to offer the highest quality of life to our patients.
* Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered.
* Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity.
* Assists staff in maintaining current and accurate medical records and utilization review.
* Assists clinical supervisor with non-clinical phone inquiries.
* Notifies supervisor of any problems requiring administrative attention and intervention.
* Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment.
* Implements all available actions to prevent avoidable hospitalization and ER visits.
* Attends training, education, seminars, or other means of learning.
* Treats patients and caregivers in the highest and most effective manner.
* Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel.
* Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care.
* Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule.
* Performs other duties/projects as assigned.
What is Required?
* 1+ year experience in a hospice or home health care setting
* Proficiency with Medical Terminology
* Experience working with clinical management team
* Proficiency with office equipment including computer, fax, copy machines
* Experience with Medicare and Medicaid guidelines are preferred
You will report to the Clinical Manager.
This is not a comprehensive list of all job responsibilities; a full will be provided.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families.
Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law.
Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9.
At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location.
This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided.
If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
Auto-ApplyClinical Research Coordinator I
Clinical research associate job in Columbia, MO
Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients.
Who We Are
ObjectiveHealth is a clinical research company that uses proprietary technology to:
* Increase patient access to research trials within our communities,
* Provide physicians with enhanced care options for current patients, and
* Deliver superior clinical research enrollment metrics to Pharma sponsors
All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.
Who You Are
* A lover of patient interaction and skilled at providing patient care
* A team player with a bias for action and an attitude that takes personal responsibility
* Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc.
* Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc.
* Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence
* An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others
* A strong advocate for Company values, mission, and initiatives
* Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies
* Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology
What Success Looks Like for This Role
* Taking ownership of assigned studies and patients
* Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction
* Showing up on time, every time
* Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies
* Learning and using the technologies we provide to increase efficiency in your day-to-day activities
* Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication
What We Offer
Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.
Requirements
This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
Clinical Research Assistant / Medical Assistant
Clinical research associate job in Kansas City, MO
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site.
Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to:
Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol:
Assists with the basic screening of patients for study enrollment;
Assists with patient follow-up visits;
Documents in source clinic charts;
Enters data in EDC and answers queries;
Obtains vital signs and ECGs;
May perform blood draws;
Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
Request and track medical record requests;
Enters data in EDC and answers queries;
Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and
Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed;
Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.
Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed;
Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and
Perform all other duties as requested or assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
Must possess strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
Must be professional, respectful of others, self-motivated, and have a strong work ethic.
Must possess a high degree of integrity and dependability.
Ability to work under minimal supervision, identify problems and implement solutions.
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Clinical Research Assistant
Clinical research associate job in Omaha, NE
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
Responsibilities
Duties/Responsibilities:
Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs
Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
Prepare source document charts, copy and/or file medical records and study related documents as required.
Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
Other duties as assigned
Qualifications
Education/Experience:
High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Required Skills:
Demonstrated knowledge of medical terminology
Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Understanding of verbal, written, and organizational skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Demonstrated ability to multi-task
Demonstrated ability to follow written guidelines
Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
Required Physical Abilities:
Sit or stand for long periods of time
Communicate in person and by a telephone
Limited walking required
Limited to lifting up to 30 pounds
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Auto-ApplyLead Clinical Research Associate
Clinical research associate job in Lenexa, KS
Lead Clinical Research Associate - Ophthalmology ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. You will be a key contributor to the success of clinical trials by driving site performance, providing mentorship to CRAs, and ensuring the highest levels of data quality and patient safety.
**What You Will Be Doing:**
+ Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines.
+ Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance.
+ Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations.
+ Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies.
+ Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.
**Your Profile:**
+ Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.
+ Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
+ In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
+ Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
+ Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (******************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (****************************************************** to apply
Clinical Research Associate II
Clinical research associate job in Memphis, MO
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Study Assistant II - Obstetrics and Gynecology
Clinical research associate job in Saint Louis, MO
Scheduled Hours 40 Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data. This research assistant will conduct study visits including patient interviews, clinician interviews, MRIs tests and other study related procedures under the guidance of clinical research coordinators and supervisors. This job will be a mix of patient focused job responsibilities and clinical data collection. An ideal candidate may have clinical research experience, specifically with vulnerable patient populations.
Job Description
Primary Duties & Responsibilities:
* Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants.
* Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed.
* Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary.
* Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information.
* Performs other duties as assigned.
Working Conditions:
Job Location/Working Conditions:
* Normal office environment.
Physical Effort:
* Typically sitting at desk or table.
* Repetitive wrist, hand or finger movement.
Equipment:
* Office equipment.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.
Required Qualifications
Education:
High school diploma or equivalent high school certification or combination of education and/or experience.
Certifications/Professional Licenses:
The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.
Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Work Experience:
Administrative Or Research (2 Years)
Skills:
Not Applicable
Driver's License:
A driver's license is not required for this position.
More About This Job
Required Qualifications:
* Basic Life Support certification must be obtained within one month of hire date.
* Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements).
Preferred Qualifications
Education:
Associate degree
Certifications/Professional Licenses:
No additional certification/professional licenses unless stated elsewhere in the job posting.
Work Experience:
No additional work experience unless stated elsewhere in the job posting.
Skills:
Interpersonal Communication, Oral Communications, Organizing, Written Communication
Grade
C07-H
Salary Range
$19.21 - $28.85 / Hourly
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.
Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Benefits Statement
Personal
* Up to 22 days of vacation, 10 recognized holidays, and sick time.
* Competitive health insurance packages with priority appointments and lower copays/coinsurance.
* Take advantage of our free Metro transit U-Pass for eligible employees.
* WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
* Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
* We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered.
* WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: ******************************
EEO Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
Auto-ApplyClinical Study Coordinator-JCCT
Clinical research associate job in Lenexa, KS
Job DescriptionDescription:
Study Coordinator
Department: Study Management
Purpose:
The Study Coordinator is responsible for the coordination and administration of clinical studies under the direction of the Director of Study Management, and the Medical Director/Principal Investigator.
Position Summary:
This position will develop, implement and coordinate research and administrative procedures for the successful management of clinical studies. The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. This position will report directly to the Clinical Study Team Manager.
Key Responsibilities (Essential Functions):
Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
Communicate with Nursing staff on an ongoing basis regarding study updates, amendments/ changes.
Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
Professional communication and collaborative work ethic with CRAs at Site visits.
Order and track supplies or devices necessary for study completion.
Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
Track enrollment status of volunteers and documentation in Clinical Conductor system.
Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
Adherent to safety and privacy regulations
Other duties as assigned
Education and Work Experience:
High school diploma or GED is required; Bachelor's degree in Science is preferred
3 to 5 years of experience in a clinical research setting or related work environment is preferred
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
Familiarity with or ability to learn clinical trial management system software
Skills and Competencies:
Excellent communication, interpersonal, analytical and problem-solving skills Microsoft Office Suite proficiency
Writing and verbal communication skills
Strong study documentation skills in compliance with ALCOA+
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc.
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Ability to prioritize and manage multiple projects simultaneously
Memory to retain information and know where to research answers
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong critical thinking, problem solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadline
Physical Requirements:
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds
Why JCCT?
JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.
We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.
Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.
If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!
EEO
JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Requirements:
Clinical Research Assistant / Medical Assistant
Clinical research associate job in Kansas City, MO
Department
Operations
Employment Type
Full Time
Location
Kansas City Research Institute
Workplace type
Onsite
Reporting To
Taleah Brown
Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
Clinical Research Assistant
Clinical research associate job in Grand Island, NE
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
Responsibilities
Duties/Responsibilities:
Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs
Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
Prepare source document charts, copy and/or file medical records and study related documents as required.
Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
Other duties as assigned
Qualifications
Education/Experience:
High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Required Skills:
Demonstrated knowledge of medical terminology
Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Understanding of verbal, written, and organizational skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Demonstrated ability to multi-task
Demonstrated ability to follow written guidelines
Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
Required Physical Abilities:
Sit or stand for long periods of time
Communicate in person and by a telephone
Limited walking required
Limited to lifting up to 30 pounds
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
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