JOB SUMMARY

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.

REQUIRED QUALIFICATIONS*

• 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.)

DESIRED QUALIFICATIONS*

• 6+ 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

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, 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, and maintaining the regulatory binder.
Expert level knowledge, skills, and abilities within 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, with daily supervision from the CRC-Lead.
Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.