This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level.This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: design, demonstrate, develop, guide, and support.
Expert level knowledge, skills, and abilities within all 8 competency domains is expected:
Scientific Concepts and Research Design
Ethical Participant Safety Considerations
Investigational Products Development and Regulation
Clinical Study Operations (GCPs)
Study and Site Management
Data Management and Informatics
Leadership and Professionalism
Communication and Teamwork
Responsibilities will include, but are not limited to:
Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data.
Track research visits ensuring compliance with protocol requirements.
Maintain accurate research records and transcribe collected data onto source documents and electronic case report forms.
Upload images, request records, and file documents appropriately for audit readiness.
Assist with identification, documentation and reporting of adverse events according to standard operating procedures and protocol requirements.
Assist with writing, editing, and renewing Institutional Review Board applications; maintain version trackers for IRB applications, informed consent documents, protocol version trackers, and other related items.
Assist with budget and billing calendar development and revisions.
Review account statements comparing against payment schedule and billing calendar to ensure accuracy.Prepare and submit requests for billing adjustments and invoices as needed.
Assures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines.
Perform study-specific tests in clinic such as mini-mental, grip test, and walk test.
Other duties as assigned or required for the research project.
Supervision Received:
This position reports directly to the Clinical Research Manager in the Department of Cardiac Surgery. Functional supervision is received from the principal investigators, co-investigators, and the VAD Program Manager.
Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. Please review eligibility criteria from SoCRAorACRPprior to applying.
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA'sDefinition of a Clinical Research Professionalfor qualifying experience prior to applying.
6+ years of direct related experience.
Demonstrated understanding of GCP, ICH, and FDA regulations.
Prior experience with Bioresearch Monitoring Program (BIMO) audits including preparatory quality assurance reviews.
Hours/Week: This is a full-time position at 40 hours/week.
Shift/Hours/Days: Days, occasional evening, potential weekends. Some overnight travel expected for study related meetings and conferences.
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.