This position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the Clinical Research Coordinator Associate position on the Michigan Medicine CRC Career Ladder is required is required. 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.
This role will include clinical trial management of Industry and NIH Sponsored Clinical Trials (Phase II-III), and Investigator Initiated Studies. Study start-up: IRB submissions, budgeting, assist with database creation and development of study collection materials. Study Maintenance: Screen, enroll, schedule, and conduct study visits. Data collection and maintenance of eCRFs ensuring trial compliance. Regulatory Maintenance: IRB amendments and renewals, maintaining the regulatory binder and ensuring regulatory compliance. Mentoring junior coordinators in the unit.
Contribute to the development of process and tools in all 8 competency domains is expected:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
Supervision Received: This position reports directly to Faculty Principal Investigator.
Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.
- 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 SoCRA or ACRP prior to applying.)
- Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
- 5+ years of direct related experience
- An understanding of medical terminology
- Ability to effectively communicate with patients, staff, and faculty of all levels
- Knowledge of University of Michigan policies and procedures is desirable, including IRBMED and FinProd
- Experience in Institutional Biosafety Committee (IBC) protocols
- Experience in basic laboratory procedures, including aliquoting, IATA shipping, handling biological specimen
- A background in financial management such as Unfunded Agreements (UFAs), Clinical Trial Site Agreements (CTAs), and budget creation is preferred
- Experience with commonly used research systems: REDCap and/or other Electronic Data Capture (EDC) software, DataDirect and/or other cohort data extraction tool
- Ability to write and design study protocols
Full Time. 40 hours per week, M-F
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.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
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 employment opportunity employer.
