Clinical Research Coord Inter

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.

• Clinical Coordinator Responsibilities - identify and screen eligible participants, conduct informed consent, monitor participants throughout the study, ensure adherence to protocol and ethical standards. Schedule and coordinate study visits as well as study procedures. Follow standard GCP and ALCOA-C. Act as liason between PI, study sponsors, participants, and institutional departments. Assist in study feasibility assessments, budget preparation, and training of study personnel. When required, attend investigator meetings.
• Regulatory Coordinator Responsibilities - maintain all regulatory documents, including CRFs, source documents, and submissions to IRB. Endure that all study activities comply with federal regulations, GCP guidelines, and sponsor requirements. Study start up activities, prepare lab kits and requisitions, ensure that all study procedures are executed according to protocol.
• Data Coordinator Responsibilities - enter, verify and maintain study data in EDC. Resolve queries, track AEs, manage accountability and document visits in EMR.

Characteristic Duties and Responsibilities:
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 a faculty PI

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 orACRP)
• 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 qualifying experience prior to applying.

• 6+ years of experience
• This person will need to either have some e-health literacy and be proficient or able to learn how to work with electronic data capture including REDCap, Oncore,IRB, SignNow electronic consents, and web-based/digital health interventions. Must be organized and able to work independently as well have strong communication skills

This position is primarily onsite with potential for hybrid in the future.