"Clinical Research Coord Inter"

Clinical Research Coordinator Intermediate

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:

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

Position specific responsibilities include:

• Maintain database of subjects with research-related data
• Manage regulatory requirements and work with IRB, CTSUs, research support units, and other research-related units in the Cancer Center, Medical School, and University regarding biorepository, clinical research, and clinical trials. This includes maintainance of all regulatory requirements in collaboration with supervisor.
• Collect, process, store, organize, and share biospecimens per SOPs and best practices
• Work with CTSUs on interventional trials and other clinical research aligned with biospecimen-specific research
• Support goals and initiatives of the Rogel and Blondy Center for Pancreatic Cancer and Rogel Cancer Center

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 training course and/or exam at date of hire and the certification must be completed or passed etc. within 6 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.)
• Experience in managing and maintain administrative data and database.

Preferred Qualification:

• 6+ years of direct related experience

This will be a M-F 8-5 position with occasionally needing to stay a little later (based on OR scheduling) but also allows for flexibility in coming in later those days. Estimating less than 10% of the days worked (1-2 days/month at most).

Supervision Received: This position reports directly to Associate Director for Clinical Research at Rogel and Blondy Center for Pancreatic Cancer.

Supervision Exercised: Provide Functional supervision (in limited capacity such as training) of staff as it relates to biospecimen collection and processing.