Clinical Research Associate- CO
Clinical Research Coordinator Job 19 miles from Kansas City
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing:** + Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing
+ Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
+ Strong planning & organizational skills, and the ability to work efficiently and effectively
+ Proactive, conscientious and precise in delivery of quality work even when under pressure
+ Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner
+ Flexible with high learning and change agility
+ Knowledge of local regulations, IND/ICH GCP - guidelines,
+ Available and willing to travel as job requires
+ Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team
+ Engage and maintain good written and verbal communication with external stakeholders in order to ensure effectiveness
+ Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate
+ Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out
+ Determines the feasibility of the study protocol with reference to study complexity
+ Confirms staff availability, suitable clinical facilities, potential for per protocol patient population
+ Confirms ability to comply with ICH GCP and requirements for clinical studies.
+ Works with Study staff to carry out a local study / site level risk
+ Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator's participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.
+ Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are
+ Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).
+ Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.
+ Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
+ Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.
+ Completes monitoring visit reports within the agreed timelines
+ Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).
+ Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.
+ Ensure sponsor study records are inspection ready at all times and archives records as applicable
**You are:**
**Education required:**
+ Undergraduate degree or its international equivalent in clinical, science, or health-related fieldfrom an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience preferred
**Skills Required**
+ Read, write and speak fluent English; fluent in host country language required.
+ 2-4 years of clinical monitoring experience required
+ Knowledge of ICH and local regulatory authority regulations regarding drug
+ Clinical research experience
+ Knowledge of ICH and local regulatory authority regulations regarding drug
+ Experience in monitoring all trial components (PSSV to COV)
+ Experience in coaching/mentoring other CRA
_Pay Range ($89,740.00 USD - $134,060 USD)_
_Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level_
**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 maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below.
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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.
Clinical Research Associate - Sponsor Dedicated
Clinical Research Coordinator Job 23 miles from Kansas City
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Some organizations require completion of CRA training program or prior monitoring experience.
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. **********************/eoe
IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. **********************/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Coordinator - Internal Medicine (Nephrology)
Clinical Research Coordinator Job In Kansas City, KS
Department:SOM KC Internal Medicine - Nephrology and Hypertension
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Medicine - Nephrology and HypertensionPosition Title:Senior Clinical Research Coordinator - Internal Medicine (Nephrology) Job Family Group: Professional Staff Summary:The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.:
Job Duties:
Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
Transplant patients can be admitted at any time day or night. This position may require work over the weekend, nights, or holidays, depending on enrollment and transplant schedule. Coordinators will take a rotating call schedule for coverage.
Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice.
As requested, facilitate monitoring visits, reviews, and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Prepare and maintain clinical trial contract documents and study budget reports.
Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies, and study participants.
Prepare documentation and participate in study monitoring visits, reviews, and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Attend continuing education, research and training seminars as requested by manager.
Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria, and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
Reviews and assists with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget, and specific needs for the study.
Assist Principal Investigators with internal and external funding application submissions.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Education: Bachelor's degree or an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
Certifications: Research certification (CCRC or CCRP)
Work Experience:
4 years related work experience
Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
In-depth knowledge of study budgets, contracts, and grant applications.
Preferred Qualifications
Education: Master's degree in relevant field.
Work Experience: Business and financial acumen to assist in developing study budgets, contracts, and grant applications.
Skills
Excellent communication, writing, organizational and presentation skills.
Ability to fully contribute to multidisciplinary teams including physicians, administrative staff.
Ability to effectively manage competing priorities and deadlines.
Required Documents
Resume/CV
Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type: RegularTime Type: Full time Rate Type: Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$65,000.00 - $99,000.00
Minimum
$65,000.00
Midpoint
$82,000.00
Maximum
$99,000.00
Clinical Research Associate 2 - Oncology - Southeast - United States
Clinical Research Coordinator Job In Kansas City, KS
Who we are
We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Clinical Operations Department does at Worldwide
As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs.
Through regular touchpoints and coaching conversations with your Line Manager, we ensure that your professional development remains a top priority. We offer a clear career path and development that can lead to Clinical Trial Manager roles. We take pride in our accessible Executive Leadership team, who are equally committed to advancing science and surmounting obstacles to make a difference in the lives of patients around the world.
We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial. Experience a world of difference with us Worldwide!
What you will do
Conduct all types of visits - site qualifications, initiation, interim monitoring, site management and study close-out visits
Review study subject safety information and informed consent and conduct source document verification for compliance, patient safety, and veracity of data
Actively participate in study team and investigator meetings
Compile and ensure completeness of regulatory documents and ethical submission documentation and review study subject safety information and informed consent and study material (e.g. CRFs, manuals)
What you will bring to the role
Excellent interpersonal, oral, and written communication skills in English and local language
Superior organizational skills with attention to detail, and the ability to work independently
Broad understanding of clinical research principles and process
Proficiency in Microsoft Office, CTMS, and EDC Systems
Your experience
At least two years of independent clinical monitoring experience
Demonstrable experience in handling multiple protocols across a range of therapeutic indications
Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree)
Ability to meet the travel requirements of the job
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Senior Clinical Research Coordinator - Cancer Center (MCA)
Clinical Research Coordinator Job In Kansas City, MO
Department: SOM KC Cancer Center Administration * ---- Masonic Cancer Alliance Senior Clinical Research Coordinator - Cancer Center (MCA) Job Family Group: Professional Staff The Senior Clinical Research Coordinator works collaboratively with Masonic Cancer Alliance (MCA) member sites and multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of complex clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
* This position may be eligible for a hybrid work schedule after 6 months. Incumbent will work remotely and on campus based on a set departmental schedule based on management approval and must reside in the greater Kansas City metropolitan area.*
This position will require travel up to 20% to member sites.
The University of Kansas Cancer Center (KUCC) is the region's only National Cancer Institute designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Job Description:
Job Duties Outlined:
* Under the direction of the KUCC-MCA MU NCORP principal investigator evaluate potential patient eligibility for clinical trials.
* Assist MCA clinical staff with maintaining source documents and submit electronic case report forms (CRFs) as required for clinical trials.
* Assure that clinical trial is conducted in accordance with all KUMC and other regulatory requirements.
* Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
* Prepare documents for distribution to MCA sites regarding eligibility and training for new trials.
* Assist clinical staff with understanding study procedures, as outlined in the protocol, reporting protocol deviations and developing corrective and preventive plans as needed.
* Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
* Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
* Attend continuing education, research and training seminars as requested by manager, including KUCC disease working group meetings and national NCTN meetings.
* Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
* As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
* Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
* Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study if inclusion of MCA sites.
* Assist Principal Investigators with internal and external funding application submissions.
Required Qualifications
Education: Associate's degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 8 years.
Certification: Research certification required such as Socra, Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
Work Experience:
* Demonstrated advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).
* Demonstrated advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
* In-depth knowledge of study budgets, contracts, and grant applications.
Preferred Qualifications
Education: Master's degree in relevant field.
Skills:
* Cooperative trial experience and/or strong oncology background.
* Attention to detail, organizational, and time management skills.
* Communication skills both written and verbal.
* Computer skills ie: MSO Suite: Outlook, Windows, Excel and Word.
Required Documents:
* Resume/CV
* Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type:
Regular
Time Type:
Full time
Rate Type:
Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:
$65,000.00 - $99,000.00
Minimum
$65,000.00
Midpoint
$82,000.00
Maximum
$99,000.00
Senior Clinical Research Coordinator
Clinical Research Coordinator Job In Kansas City, MO
+ The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials. Working in collaboration with the Principal Investigator, the Sr. CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.
+ The Sr. CRC works collaboratively with the entire team, sponsors, and Clinical Quality Associates to ensure productivity, quality, and timely completion of studies.
+ The Sr. CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities.
+ The Sr. CRC applies critical thinking and creative problem-solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards.
**Responsibilities:**
+ Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants)
+ Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.
+ Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
+ Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial.
+ Function as participants' primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events)
+ Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
+ Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator
+ Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and databases.
+ Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.
+ Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
+ Maintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrolment)
+ Maintain study supplies and issue appropriate participant stipends.
+ Ensures appropriate credentialing and training of the study team.
+ Facilitate meetings with the study monitors, auditors, and investigators.
+ Ensure timely response to queries and documentation of study-related issues.
+ If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary.
+ Contribute to the development and implementation of tools, processes, and training to enhance the administration and execution of clinical studies (e.g., GCP, ALCOA-C)
+ Accountable for site compliance with subject safety reporting, escalate issues.
+ Demonstrate professionalism and apply basic leadership practices in all aspects of the role.
+ Train and support study team members on a range of communication and teamwork best practices
+ Performs other duties related to the clinical trials as delegated by the Principal Investigator
**Experience:**
+ 3-5 years of Clinical Trial experience.
**Skills:**
+ standard operating procedures (SPOs), Food and Drug Administration (FDA), Clinical Trials.
**Education:**
+ High School Diploma or associate degree.
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (********************************** .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,
national origin, disability, or status as a protected veteran.
Sr. Clinical Research Coordinator (Kansas City, MO)*
Clinical Research Coordinator Job In Kansas City, MO
The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available.
Mission, Vision, Values
o Mission: Improving Lives by Providing Advanced Therapeutic Options
o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research.
o Values:
o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions.
o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.
o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions.
o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.
Profound Ethos
o Physicians are the Vanguard
o All Decisions Improve Patient Care
o Never Compromise Quality
Role: Senior Clinical Research Coordinator
Company: Profound Research
Locations: Kansas City, MO
Role & Responsibilities:
-Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
-Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
-Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
-Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up.
-Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
-Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met.
-Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
-Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
-Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
-Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.
-Other duties as assigned.
Requirements & Skills:
-BS/BA in Life Sciences or related discipline and 4 years as a Clinical Research Coordinator OR
-Associate degree and 6+ years as a Clinical Research Coordinator OR
-High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator
-Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
-Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens.
-Excellent attention to detail, organization, and communication with varied stakeholders.
Physical Requirements
· Prolonged periods of sitting at a desk and working on a computer, standing and walking.
· Must be able to lift 25 pounds at times.
· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Sr Clinical Research Coordinator
Clinical Research Coordinator Job In Kansas City, MO
Thanks for your interest in Children's Mercy! Do you envision finding a meaningful role with an inclusive and compassionate team? At Children's Mercy, we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference, which is why we have been recognized by U.S. News & World Report as a top pediatric hospital, for eleven consecutive years.
Children's Mercy is in the heart of Kansas City - a metro abounding in cultural experiences, vibrant communities and thriving businesses. This is where our patients and families live, work and play. This is a community that has embraced our hospital and we strive to say thanks by giving back. As a leader in children's health, we engage in meaningful programs and partnerships throughout the region so that we can improve the lives of children beyond the walls of our hospital.
Overview
Lead day to day operations of the Fetal Health research study team conducting clinical research; perform a variety of complex duties involved in the study regulatory procedures , collection, compilation, documentation, and analysis of clinical research data; lead others in navigating the clinical research environment. Lead or participate in a variety of unit, department, or division-level national, international and multi-institutional initiatives. Oversee the work CRC I, CRC II's, and other research staff.
At Children's Mercy, we are committed to ensuring that everyone feels welcomed within our walls. A successful candidate for this position will join us as we strive to create a workplace that reflects the community we serve, as well as our core values of kindness, curiosity, inclusion, team and integrity.
Additionally, it's important to us that we remain transparent with all potential job candidates. Because we value the safety of the patients and families we serve, as well as the Children's Mercy staff, we want to let you know that the seasonal influenza vaccine is a condition of employment for all employees in our organization. New employees must be willing to be vaccinated if found non-immune to measles, mumps, rubella (MMR) and chicken pox (varicella) and/or without evidence of tetanus, diphtheria, acellular pertussis (Tdap) vaccination since 2005. If you are selected for this position, you will be asked to supply your immunization records as proof of vaccination. If you and have any concerns about receiving these vaccines, medical and/or religious exemptions can be further discussed with Human Resources.
Responsibilities
+ Research Operations
+ Regulatory Support
+ Data Capture Management
+ Staff Training/Research Education
+ Financials/Fiscal Management
Qualifications
+ Master's Degree and 3-5 years experience or
+ Bachelor's Degree and 5-7 years experience
+ One of the following: Certified Clinical Research Coordinator, Certified Clinical Research Associate, Certified Clinical Research Professional, Assoc of Clinical Research Professionals - Cert Professional, Assoc of Clinical Research Professionals - Medical Device Pr, Assoc of Clinical Research Professionals - Project Manager required upon hire
+ ACRP-PM Assoc of Clinical Research Professionals- Project Manager OR Required Upon Hire
+ ACRP-MDP Assoc of Clinical Research Professionals - Medical Device Professional Required Upon Hire
Benefits at Children's Mercy
The benefits plans at Children's Mercy are one of many reasons we are recognized as one of the best places to work in Kansas City. Our plans are designed to meet the changing needs of our employees and their families.
Learn more about Children's Mercy benefits. (******************************************************************************
Starting Pay
Our pay ranges are market competitive. The pay range for this job begins at $31.31/hr, but your offer will be determined based on your education and experience.
Remote Work/Work from Home
This is an intermittent remote position, which means that the person hired will work with his or her manager to determine a schedule that includes both at home and on-site hours at a Children's Mercy location. The incumbent must live in the Kansas City metro area.
EEO Employer/Disabled/Vet
Children's Mercy hires individuals based on their job skills, expertise and ability to maintain professional relationships with fellow employees, patients, parents and visitors. A personal interview, formal education and training, previous work experience, references and a criminal background investigation all are factors used to select the best candidates. The hospital does not discriminate against prospective or current employees based on the race, color, religion, sex, national origin, age, disability, creed, genetic information, sexual orientation, gender identity or expression, ancestry or veteran status. A drug screen will be performed upon hire. Children's Mercy is smoke and tobacco free.
Our commitment to Diversity & Inclusion
CM is committed to creating a diverse and inclusive workforce. Our patients and families come from all walks of life, and so do we. We know that our greatest strengths come from the people who make up our team so we hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our hospital stronger and our patient care more compassionate.
If you share our values and our enthusiasm for service, you will find a home at CM. In recruiting for our team, we welcome the unique contributions that you can bring, including education, ideas, culture, ethnicity, race, sex, sexual orientation, gender identity and expression, national origin, age, languages spoken, veteran status, color, religion, disability and beliefs.
Need help finding the right job?
We can recommend jobs specifically for you! Learn about Children's Mercy Benefits (*****************************************************************************************************
Requisition ID2024-31674
Requisition Post Information* : Posted Date2 months ago(12/13/2024 1:49 PM)
Posting CategoryResearch
DivisionRESEARCH CORE
Work TypeFull Time
Work DaysMonday through Friday
Work Hours0800-1600
FLSA StatusExempt
Location : NameAdele Hall
Recruiter : Full Name: First LastJulie Aust
Recruiter : *******************
Sr. Clinical Research Coordinator (Kansas City, MO)*
Clinical Research Coordinator Job In Kansas City, MO
The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o Mission: Improving Lives by Providing Advanced Therapeutic Optionso Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research.o Values: o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.
Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality
Role: Senior Clinical Research Coordinator Company: Profound Research Locations: Kansas City, MO
Role & Responsibilities: -Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements. -Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met. -Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned.
Requirements & Skills: -BS/BA in Life Sciences or related discipline and 4 years as a Clinical Research Coordinator OR -Associate degree and 6+ years as a Clinical Research Coordinator OR -High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred. -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens. -Excellent attention to detail, organization, and communication with varied stakeholders. Physical Requirements· Prolonged periods of sitting at a desk and working on a computer, standing and walking.· Must be able to lift 25 pounds at times.· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Clinical Study Coordinator
Clinical Research Coordinator Job 19 miles from Kansas City
Clinical Study Coordinator Full-Time - On-Site 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 Study Coordinator to join our diverse and dynamic team. As a Clinical Study Coordinator 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
* Collaborating with cross-functional teams to develop and implement clinical trial protocols.
* Coordinating and overseeing the execution of clinical studies, ensuring adherence to protocols and regulatory requirements.
* Managing study timelines, budgets, and resources effectively.
* Facilitating communication between investigative sites, sponsors, and internal teams.
* Ensuring data accuracy and completeness through regular monitoring and quality control activities.
Your profile
* Bachelor's degree in a relevant scientific discipline.
* Proven experience as a Clinical Study Coordinator or in a similar role.
* Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
* Strong organizational and multitasking skills.
* Excellent communication and interpersonal abilities.
#LI-MM2
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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 Coordinator - Neurology
Clinical Research Coordinator Job In Kansas City, MO
Department:SOM KC Neurology - Neuromuscular
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Neuromuscular StaffPosition Title:Clinical Research Coordinator - NeurologyJob Family Group: Professional Staff Summary: Summary The Clinical Research Coordinator works with multidisciplinary teams including patients/ study participants, families, physicians, and administrative staff to coordinate all aspects of clinical trial activities within the Neuromuscular Disease Program. Through careful and well-planed methods, this position ensures that study procedures follow the sponsor's protocol and all applicable regulatory requirements while also ensuring research participants and their families are treated with the utmost respect and concern for their well-being and safety.:
Job Duties
The Clinical Research Coordinator position is responsible for recruiting, evaluating, and educating patients regarding clinical trials related to neuromuscular disease. This position coordinates all aspects of assigned research studies including recruitment, study visit activities according to protocol, maintenance of the investigator site file, data entry, and other various tasks.
The Clinical Research Coordinator collaborates with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors study participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
This position will be or become familiar with neuromuscular disease and conducting research according to ICH GCP guidelines.
The position requires an individual with exceptional communication skills and the ability to multi-task to work collegially with members of the neuromuscular research team to ensure research studies are being conducted according to protocol.
Recruits, evaluates, and educates patients regarding clinical trials related to neuromuscular disease.
Conducts Informed Consent Interview with participant and caregiver following Neuromuscular Program Standard Operating Procedures (SOP) for obtaining consent from cognitively normal and cognitively impaired individuals. Follows SOP for determination of when use of a Surrogate consent form is necessary, due to extent of cognitive impairment.
Documents trial related activities per regulatory requirements in a timely and accurate manner.
Coordinates all aspects of study visit activities for patients and families, including scheduling of hospital-based procedures such as MRI and PET, and other procedures to include clinical study visit interviews and assessments, ECG, lab draws, IV infusions, lumbar punctures, and dispensation of study medication.
Gathers accurate medical history and concomitant medication information and ensures that medical conditions and medications meet trial specifications.
Probes patient/ caregiver for any changes in health throughout clinical trial intervention and monitors for potential adverse events. Obtains complete reports of new symptoms/changes in health conditions and reviews with clinician/principal investigator. Based on principal investigator's determination of adverse event (AE) qualification, prepares formal AE report for sponsor and for IRB, when applicable per regulations. If AE meets criteria of Serious Adverse Event (SAE), prepares full FDA MedWatch or sponsor-provided Safety Report and submits to regulatory authorities within 24 hours of learning of event.
Assists physician in cerebrospinal fluid (CSF) collection for clinical trials by educating patient / caregiver regarding the lumbar puncture procedure, preparing lumbar puncture supplies, providing supplies to physician during procedure while maintaining sterile field, aliquoting CSF by protocol-specified amounts into separate vials for storage and transport, instructing patient/caregiver in post-lumbar puncture care and expectations, conducting follow -up phone call to determine if any adverse events were experienced.
Prepares local and central lab requisition forms to ensure proper testing is conducted on CSF, blood, and urine samples.
Prepares and ships biological specimens to central labs per protocol and regulatory requirements.
Conducts interviews with patient and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.
Ensures all study staff completes required training for proper conduct of the trial.
Ensures investigator's timely review of lab tests, EMG/ECG/MRI/PET results and communicates clinically relevant information to patient and patient's primary care doctor as appropriate.
Ensures availability of medical records, updated subject records and updated protocols.
Updates and maintains regulatory binders.
Prepares adverse event reports and protocol deviation reports for submission to IRB.
Assists the Research Institute regulatory project manager in preparation of IRB submissions, including review of consent forms, nw study and continuing review applications, and protocol amendments.
Ensures all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.
Must be available to travel to attend national meetings
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Education:Associate degree plus two years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
Work Experience:
Experience using the Microsoft Office Suite.
Two (2) years of relevant work experience.
Experience working with patients, families, physicians, and administrative staff.
Preferred Qualifications
Education/Certifications: SOCRA CCRP certification
Work Experience
Prior health care and/or research experience.
Experience with electronic medical records.
Experience in Neurology and/or Neuromuscular research.
Skills
Attention to detail
Time-management skills.
Interpersonal skills.
Multitasking skills.
Required Documents
Resume/CV
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type: RegularTime Type: Full time Rate Type: Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$58,656.00 - $86,000.00
Minimum
$58,656.00
Midpoint
$72,328.00
Maximum
$86,000.00
Trials and Research Coordinator - eShepherd
Clinical Research Coordinator Job In Kansas City, KS
The Company Our purpose at Gallagher is to 'protect what matters most' and we live it every day. Not only does our technology protect some of the world's highest security environments and agriculture businesses in over 160 countries, but our purpose also means we care deeply about our people and their families. Gallagher has been in business for almost 85 years, and we are just as committed to creativity and innovation today as when we started. Headquartered in New Zealand, and with offices in 10 locations around the world, we're proud to employ over 1400 people throughout #TeamGallagher. The North American market has experienced exponential growth over the last four years. We have offices located in Riverside, MO, Canton, GA and Owen Sound, Canada.
The Product
Throughout our history we've been known to develop award-winning solutions, and now we're launching the next. Named eShepherd, this future farm technology allows farmers to monitor, move and contain livestock anywhere on their ranch, breaking down those difficult to fence paddocks into smaller grazing cells to run a more efficient and thriving pasture-based system. Our technology provides real-time data and 24/7 visibility of livestock, increasing productivity and profitability, improving animal health outcomes, and offering a cost-effective solution for environmental compliance and sustainable practices. eShepherd is a solar powered, GPS enabled, livestock neckband that enables you to simply draw your virtual fence anywhere on your property and your cattle learn to move with and remain within the virtual barrier.
The Role
We have an exciting opportunity for a Trials and Research Coordinator to join our team in Kansas City and continue our testing and research related to our eShepherd virtual fencing products.
In this role you will be working with the Research and Innovation Manager to support the planning and coordinating of commercial testing activities globally, managing participant relationships, collecting and analyzing data or organizing the collection and analysis of data, and ensuring smooth execution of commercial testing projects.
* Contribute to the planning, development and management of commercial testing methods and schedules, ensuring a smooth partnership with our testing partners on farm.
* Serve as a primary point of contact for our farmers and ranchers enabling good connection, data collection and support for good outcomes for our product and on farm.
* Prepare and present regular updates to stakeholders on commercial testing progress and findings.
* Collaborate with development teams to communicate participant feedback and prioritize issues.
* Maintain accurate and up-to-date documentation of all commercial testing processes, communications, results, and outcomes.
The Fit
To thrive in this role, you will need a diverse background in on-farm activities and research. You will bring strong problem-solving and adaptability to deliver quality trial outcomes in challenging circumstances. This role will require some of the following:
* Strong understanding of and experience in animal handling is a necessity
* A relevant qualification or experience in biological/agricultural science research coordination, project management, or similar
* A good practical understanding of farming business, practice, and technology; especially those that are potentially disruptive in agriculture.
* Proficiency in data analysis and reporting tools (e.g., Excel, SPSS, Tableau, Power BI).
* Strong emotional intelligence (EQ) and well-developed communication skills to build effective working relationships with our customers and across the eShepherd team.
* Ability to work independently and collaboratively in a fast-paced environment.
* Familiarity with commercial testing processes and animal research methodologies.
* Ability to review and concisely summarise complex animal science topics.
Diversity
Gallagher is an equal opportunity employer and ensures nondiscrimination and equal employment opportunity in all programs and activities in accordance with all applicable laws and regulations. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, pregnancy status, marital status, sexual orientation, genetic information, citizenship status, disability, protected Veteran status or any other status protected by law. In compliance with the Immigration Reform and Control Act of 1986, we will hire only U.S. citizens and aliens lawfully authorized to work in the United States (if the position is or will be one which is subject to U.S. law).
Why Gallagher?
This is a fantastic opportunity to part of a once in a generation shift in grazing practices that will improve productivity, profitability and environmental outcomes for North American farmers. You'll be joining a responsive future focused team with a supportive, flexible and high-performing work culture.
Competitive compensation package including bonus potential, and company laptop.
Available benefits include medical, dental, vision, life insurance, accidental death & dismemberment, critical illness, accident insurance, 401K plan, paid time off (PTO), identity theft protection and an Employee Assistance program.
Culture of high trust, empowerment, and teamwork, where ambition and performance are rewarded.
Business / travel related costs are covered.
Have we sparked your interest? Send your application through now and join #TeamGallagher on this exciting journey.
Senior Clinical Research Associate
Clinical Research Coordinator Job 23 miles from Kansas City
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Research Associates for coverage on the East Region. The incumbents may be required to travel to other locations across the USA to support monitoring activities as necessary.
Key Accountabilities:
Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.
Identify potential sites for participation in clinical trials.
Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.
Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.
Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.
Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).
Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.
Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.
Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site's patient recruitment/retention success and offer suggestions for improvement.
Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.
Submit accurate and on-time expense reports.
Assist with preparation of materials for Requests for Proposals and bid defenses.
Assist the Clinical Operations team with additional related tasks as needed.
Plan and carry out professional development.
Complete timesheets as requested and on-time.
Qualifications and Experience:
Bachelor's degree in a Life Science or related field of study.
Minimum of 4 years' of relevant and/or monitoring experience.
Thorough knowledge of ICH-GCP guidelines and applicable regulations.
Thorough comprehension of medical terminology.
Excellent organization and communication skills (both verbal and written).
Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.
Must maintain a valid driver's license and be able to drive to monitor sites.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ****************
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
#LI-Remote
#LI-MG1
Clinical Study Coordinator
Clinical Research Coordinator Job 23 miles from Kansas City
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 Study Coordinator carries out assigned tasks associated with the collection, documentation, and maintenance of clinical data. Work closely with Clinical Research Coordinators and assist them in the conduct of the clinical research protocols.
Responsibilities
Duties/Responsibilities:
Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs
Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors
Apply good documentation practices when collecting and correcting data, transferring data tosponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidentialinformation and Velocity confidential information
Assist in ensuring patient safety is upheld and all adverse events, serious adverse events, andadverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs
Assist in ensuring all data is entered into the sponsor's and/or vendor's data portal and all queries are resolved in a timely manner
Assist in ensuring staff are delegated and trained appropriately and training is accurately documented
Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope of the protocol and local law and regulations.
Promote respect for cultural diversity and conventions with all individuals.
Other duties as assigned
Qualifications
Education/Experience:
Associate's degree OR
High School Graduate and/or technical degree with minimum of 1 year relevant experience in the life science 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.
Basic ability to work in a fast-paced environment
Demonstrated verbal, written, and organizational skills
Demonstrated interpersonal and communication skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Basic ability to multi-task
Demonstrated ability to follow written guidelines
Basic ability to work independently, plan and prioritize with some guidance
Basic ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.
Required Physical Abilities:
Sit or stand for long periods of time
Travel locally
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.
Senior Experience Researcher
Clinical Research Coordinator Job In Kansas City, MO
Recruiting for this role ends on July 30, 2025 As a Senior Experience Researcher for Deloitte DT-US Product Engineering team, you will work with a creative group in a dynamic and fast-paced environment. Strategically design, plan, and execute user research studies and analyze behavioral metrics to paint a complete picture of our users to drive design decisions and user experience priorities. This role requires a proven track record of user research strategy and execution using a deep toolbox of methodologies to explore behavior, workflow and motivations of our users. Passion for blending qualitative and quantitative research to inform design strategy, rapid prototyping, and iterative testing for continuous improvement essential. Join us in shaping the future of design!
Key Responsibilities:
+ Define research strategy, design, and execute research studies effectively
+ Provide user research expertise and execution across products in a cross-functional environment.
+ Develop appropriate research methodologies and test plans for products, employing innovative approaches that are the best fit for individual products or areas
+ Conduct research using a wide variety of qualitative and quantitative methods to generate actionable insights across the product development lifecycle, from generative research to identify new opportunities, iterative concept evaluation, and post-launch testing
+ Conduct internal cross-functional workshops using design-thinking methodologies to drive collaboration
+ Synthesizes research results into usable assets such as user personas, and translates research results into valuable and delightful design opportunities
+ Collaborate with empowered product teams to define success metrics from both qualitative and quantitative perspectives, aligning research with business goals
+ Connects the entire product team with users through communication of user research results in an easily consumable way tied to user outcomes
+ Develop a systematic approach to collecting, sharing, and communicating research insights with product teams to inform design improvements
+ Use research insights to inform product strategy and uncover new opportunities based on user needs.
+ Advocate for research findings in a compelling way that inspires action across teams.
+ Drive and recommend proactive, broad-based research programs across products and businesses to address key areas of focus.
+ Work closely with UX designers to translate research findings into actionable design recommendations and stay embedded to support their implementation.
+ Partner with empowered product teams to prioritize and identify key research topics.
+ Stay up to date on UX, user research, and behavioral analytics trends, best practices, and methodologies.
+ Create regular summary dashboards to share key research findings and insights with management teams.
+ Exhibit expertise in driving the data strategy across multiple listening channels, such as usage metrics, surveys, and usability testing.
+ Respond to ad hoc requests for metrics to guide design and product decisions.
+ Regularly provide insights to designers and empowered product teams on key behavioral metrics, such as tool usage, search behavior, feature engagement, user demographics, and pathway analysis.
+ Spreads knowledge, practices, and improvements in experience vertical community of practice. Stays current with trends in UX.
Required Qualifications:
+ Bachelor's degree in Cognitive Psychology, Experimental Psychology, or a related field
+ Minimum 5 years of conducting comprehensive research across multiple methodologies, driving actionable insights that shape product development and customer success
+ Demonstrated experience developing/utilizing user research methodologies including focus groups, ethnography, concept validation, usability testing, card sorting, surveys, mobile testing, etc.
+ Demonstrated experience developing creative, strategic research plans that seamlessly connect big-picture thinking with detailed execution.
+ Limited immigration sponsorship may be available
+ Ability to travel 0-10%, on average, based on the work you do and the clients and industries/sectors you serve
Preferred Qualifications:
+ Advanced education degrees are desirable.
+ Master of User Research craft, recognized for expertise in both qualitative and quantitative research methods, and for fostering a culture of learning and innovation.
+ Advanced analytical and problem-solving skills, with a strong foundation in data analysis, statistical methods, and the creation of metrics dashboards.
+ Proven communication and collaboration skills, with the ability to present research findings clearly and influence decisions across all levels of the organization.
+ Proficient in using research insights to advocate for a customer-focused and product-driven mindset.
+ Adept at conducting rapid, iterative research to inform product decisions and identify simple solutions to complex problems.
The team: US Deloitte Technology Product Engineering has modernized software and product delivery, creating a scalable, cost-effective model that focuses on value/outcomes that leverages a progressive and responsive talent structure. As Deloitte's primary internal development team, Product Engineering delivers innovative digital solutions to businesses, service lines, and internal operations with proven bottom-line results and outcomes. It helps power Deloitte's success. It is the engine that drives Deloitte, serving many of the world's largest, most respected companies. We develop and deploy cutting-edge internal and go-to-market solutions that help Deloitte operate effectively and lead in the market. Our reputation is built on a tradition of delivering with excellence.
Information for applicants with a need for accommodation: ************************************************************************************************************
The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $ 80 , 4 00 - $ 148 , 0 00.
You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.
Clinical Research Coordinator
Clinical Research Coordinator Job In Kansas City, MO
The Clinical Research Coordinator manages clinical trials and ensures compliance with protocols and regulations. The Clinical Research Coordinator is responsible for patient recruitment, data management, coordination with investigators and sponsors, and ensuring ethical research and accurate documentation.
KC CARE CULTURE CODE
KC CARE follows a culture code in all we do. Our code determines how we work, treat each other, and move health equity forward. As an employee of KC CARE, you will:
* Put patients first, always
* Treat all people with dignity, respect, and kindness
* Create safe places for others to share their voice; encourage creativity
* Always strive for improvement; keep learning
* Own your work, action, and mistakes - no one is perfect
* Have fun - work should be fun, and we want you to have fun at KC CARE
KC CARE CULTURE VALUES
Exceptional Service: We value exceptional service in providing unconditional whole-person care to everyone with the promise of a personalized and affirming experience for patients. We promise to treat internal and external partners with dignity, respect, and kindness to facilitate the opportunity for all to succeed.
Inclusion and Belonging: We value diversity, equity, inclusion, and belonging by focusing on differences that promote creativity and acceptance across the organization. We promise to create a safe environment for individuality to flourish.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
* Works closely with the clinical Principal Investigator and research team to meet clinical trial outcomes.
* Collaborates closely with Principal Investigator and research team to coordinate all study activities including source document creation, recruiting patients, performing study visits, monitoring patient's study progress, entering study data into study systems, maintaining regulatory binders, and acting as primary point of contact for study sponsors.
* Coordinates and manages clinical studies according to Office for Human Research Protection and other regulatory requirements.
* Develops in-depth knowledge of assigned study protocols and communicates protocols to study patients and other internal team members.
* Ensures all work is in full compliance with protocol, applicable regulations, and sponsor expectations.
* Prepares laboratory specimens for analysis, monitors tests and procedures, and ships specimens.
* Maintains patient records in the health center's electronic health record. .
MINIMUM REQUIREMENTS
* Two years' clinical research experience
* Knowledge of and ability to follow Good Clinical Practice (GCP) Guidelines
* Proficient with Microsoft Office programs
* Prior knowledge of electronic data capture systems (EDC)
* Proficient in medical terminology
PREFERRED REQUIREMENTS
* Three or more years' experience as a Clinical Research Coordinator
* Experience in Phlebotomy
* Bachelor's degree in nursing or other healthcare field from an accredited college or university
WORKING CONDITIONS AND DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Working Conditions
General working conditions are in a healthcare facility. As such, there is a potential exposure to virus, disease, and infection from patients while performing the duties of this job. May experience traumatic situations including psychiatric traumatized and deceased patients. Travel may be expected to community meetings, client homes, or other agencies.
Physical Demands
While performing duties of this job, employees are regularly required to sit, walk, and stand; talk and hear; both in person and by telephone; use hands repetitively to finger, handle, feel, or operate standard office or clinical equipment; reach with hands and arms; and occasionally lift up to 20 pounds.
Mental Demands
While performing the duties of this job, employees are regularly required to use written and oral communication skills; read, analyze, and interpret data, information and documents; analyze and solve non-routine and complex problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information or skills; perform highly detailed work on multiple, concurrent tasks; work under intensive deadlines with frequent interruptions; and interact with others outside of their department.
Duties and responsibilities, as required by business necessity may be added, deleted, or changed at any time at the discretion of management, formally or informally, either verbally or in writing. Scheduling, shift assignments, and location may be changed at any time, as required by business necessity.
Clinical Research Coordinator I
Clinical Research Coordinator Job In Kansas City, MO
Thanks for your interest in Children's Mercy!
Do you envision finding a meaningful role with an inclusive and compassionate team? At Children's Mercy, we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference, which is why we have been recognized by U.S. News & World Report as a top pediatric hospital, for eleven consecutive years.
Children's Mercy is in the heart of Kansas City - a metro abounding in cultural experiences, vibrant communities and thriving businesses. This is where our patients and families live, work and play. This is a community that has embraced our hospital and we strive to say thanks by giving back. As a leader in children's health, we engage in meaningful programs and partnerships throughout the region so that we can improve the lives of children beyond the walls of our hospital.
Overview
To assist and perform a variety of research, data and other research related duties in order to support the conduct of clinical research under the supervision of a CRC II, Sr. CRC, and/or Clinical Research Manager. Participates in the day to day operations related to the collection, compilation, and documentation of research data.This position will be with the Radiology department and prefers an RT(R) certification.
At Children's Mercy, we are committed to ensuring that everyone feels welcomed within our walls. A successful candidate for this position will join us as we strive to create a workplace that reflects the community we serve, as well as our core values of kindness, curiosity, inclusion, team and integrity.
Additionally, it's important to us that we remain transparent with all potential job candidates. Because we value the safety of the patients and families we serve, as well as the Children's Mercy staff, we want to let you know that the seasonal influenza vaccine is a condition of employment for all employees in our organization. New employees must be willing to be vaccinated if found non-immune to measles, mumps, rubella (MMR) and chicken pox (varicella) and/or without evidence of tetanus, diphtheria, acellular pertussis (Tdap) vaccination since 2005. If you are selected for this position, you will be asked to supply your immunization records as proof of vaccination. If you and have any concerns about receiving these vaccines, medical and/or religious exemptions can be further discussed with Human Resources.
Responsibilities
Research Operations
Regulatory Support
Data Capture Management
Research Education
Financial/Fiscal Management
Qualifications
Bachelor's Degree Health related discipline or research related field and 1-2 years experience or
Associate's Degree Health related discipline or research related field and 3-5 years experience or
HS diploma or equivalent and 7 or more years experience
Benefits at Children's Mercy
The benefits plans at Children's Mercy are one of many reasons we are recognized as one of the best places to work in Kansas City. Our plans are designed to meet the changing needs of our employees and their families.
Learn more about Children's Mercy benefits. Starting Pay
Our pay ranges are market competitive. The pay range for this job begins at $26.62/hr, but your offer will be determined based on your education and experience.
Remote Work/Work from Home
This is an intermittent remote position, which means that the person hired will work with his or her manager to determine a schedule that includes both at home and on-site hours at a Children's Mercy location. The incumbent must live in the Kansas City metro area.
EEO Employer/Disabled/Vet
Children's Mercy hires individuals based on their job skills, expertise and ability to maintain professional relationships with fellow employees, patients, parents and visitors. A personal interview, formal education and training, previous work experience, references and a criminal background investigation all are factors used to select the best candidates. The hospital does not discriminate against prospective or current employees based on the race, color, religion, sex, national origin, age, disability, creed, genetic information, sexual orientation, gender identity or expression, ancestry or veteran status. A drug screen will be performed upon hire. Children's Mercy is smoke and tobacco free.
Our commitment to Diversity & Inclusion
CM is committed to creating a diverse and inclusive workforce. Our patients and families come from all walks of life, and so do we. We know that our greatest strengths come from the people who make up our team so we hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our hospital stronger and our patient care more compassionate.
If you share our values and our enthusiasm for service, you will find a home at CM. In recruiting for our team, we welcome the unique contributions that you can bring, including education, ideas, culture, ethnicity, race, sex, sexual orientation, gender identity and expression, national origin, age, languages spoken, veteran status, color, religion, disability and beliefs.
Clincal Research Coordinator II (Contract)
Clinical Research Coordinator Job In Kansas City, MO
JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR II
POSITION DESCRIPTION: The Clinical Research Coordinator II (CRC) reports to the Regional Research Manager and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
RESPONSIBILITIES:
Responsible for up to 10 studies and expected to perform 20-40 visits a month.
Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
Responsible for chain of custody and accurate accountability of investigation product and devices.
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with joint counts and other efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Serves as a liaison to all physicians, AARA employees, and third party vendors.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Maintaining office supply inventory while keeping an organized office space.
Travel as necessary for Investigator Meetings and other AARR sites.
Requirements
Qualifications:
Bachelor's Degree
1 year experience as a clinical research coordinator
Individual must have or be working towards obtaining Clinical Research Coordinator Certification (CRCC).
Must have in-depth knowledge of medical procedures and clinical terminology
CPR certified
Possess strong organizational skills
Ability to develop and maintain strong professional relationships with all providers and research subjects
Maintains confidentiality of patient and study information
Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations
Understands and supports specific State regulations governing clinical research
Excellent verbal and written communication skills
Ability to lift 20 pounds
Willing and able to travel for Investigator Meeting and training
Field-Based HSS Clinical Coordinator - Shawnee, Douglas, Leavenworth, Wyandotte, Sedgwick Counties, KS & Surrounding Areas
Clinical Research Coordinator Job 38 miles from Kansas City
At UnitedHealthcare, we're simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people for the better. Come build the health care system of tomorrow, making it more responsive, affordable, and equitable. Ready to make a difference? Join us to start **Caring. Connecting. Growing together.**
The **Long-Term Services and Supports (LTSS) Care Coordinator** is responsible for establishing a set of person-centered goal-oriented, culturally relevant, and logical steps to ensure that a person receiving LTSS receives services in a supportive, effective, efficient, timely and cost-effective manner. Care coordination includes case management, disease management, discharge planning, transition planning, and addressing social determinants of health and integration into community.
This position is a Field-Based position with a Home-Based office. Expected travelling 2-3 days per week within 30-60-mile radius.
If you reside within **Shawnee, Douglas, Leavenworth, Wyandotte, Sedgwick Counties or surrounding area** , you will enjoy the flexibility to telecommute* as you take on some tough challenges.
**Primary Responsibilities:**
+ Assess, plan, and implement care strategies that are individualized by the individual and directed toward the most appropriate, least restrictive level of care
+ Identify and initiate referrals for social service programs, including financial, psychosocial, community and state supportive services
+ Manage the person-centered service/support plan throughout the continuum of care
+ Communicate with all stakeholders the required health - related information to ensure quality coordinated care and services are provided expeditiously to all persons
+ Advocate for persons and families as needed to ensure the persons needs and choices are fully represented and supported by the health care team
+ Conduct home visits in coordination with person and care team, which may include a community service coordinator
+ Conduct in-person visits which may include nursing homes, assisted living, hospital or home
+ Serve as a resource for community care coordinator, if applicable
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
**Required Qualifications:**
+ Bachelor's Degree in social work, rehabilitation, nursing, psychology, special education, gerontology, or related human services area
+ 2+ years of experience working within the community health setting in a healthcare role
+ 1+ years of experience working with persons with long-term care needs
+ 1+ years of experience working with persons receiving services on one of the home and community based waivers in KS
+ 1+ years of experience working with MS Word, Excel and Outlook
+ Ability to travel in assigned region to visit Medicaid members in their homes and / or other settings, including community centers, hospitals, or providers' offices
**Preferred Qualifications:**
+ Licensed Social Worker or clinical degree
+ Registered Nurse
+ Background in managing populations with complex medical or behavioral needs
+ Experience with electronic charting
+ Experience with arranging community resources
*All Telecommuters will be required to adhere to UnitedHealth Group's Telecommuter Policy.
The salary range for this role is $28.61 to $56.06 per hour based on full-time employment. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you'll find a far-reaching choice of benefits and incentives.
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location, and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups, and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity / Affirmative Action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law._
_UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment._
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Clinical Associate (PRN)
Clinical Research Coordinator Job 6 miles from Kansas City
SUMMARY: Under the direction of the Director of Nursing, RN, LPN, will assist in the care of patients by performing basic nursing care and support tasks on assigned units. EXPERIENCE: Hospital experience preferred OTHER: Basic computer skills. Enrollment in a nursing program with completion of fundamentals course.
LICENSE/CERT: Required: BLS (Basic Life Support) from AHA (American Heart Association)
EDUCATION: Required: High School or Equivalent