Clinical Research Coord Senior/intermediate - Military Veterans

The Division of Rheumatology in Internal Medicine are seeking an experienced, independent, positive, organized individual with excellent record-keeping skills as a Clinical Research Coordinator Senior Position. The job will entail working with principal investigators to maintain a large, longitudinal cohort of skin and systemic autoimmune diseases and to launch and coordinate translational and clinical research trials. The position will interface with clinical research teams in Dermatology and Rheumatology. Opportunities for growth include expansion of clinical trial work, supervision of junior coordinators and program management.

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-Intermediate position on the Michigan Medicine CRC Career Ladder is required, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management and participating in training and development of junior clinical research professionals. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position 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, develop, evaluate, guide, mentor, and support.

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

• Draft initial IRB submissions
• Subject Recruitment and management
• Maintain Subject logs (screening, enrollment, visit schedule, etc.)
• Subject Scheduling
• Coordination with other study staff
• Create and maintain adequate source documents or CRFs
• Data Entry into eCRFs
• Resolve Queries
• Maintain essential documents
• IRB renewals, amendments, protocol deviations and safety reporting
• Upkeep of study staff training and delegation logs
• Maintenance of site staff training, CVs, licenses etc.
• Sponsor communication/correspondence
• Facilitate Monitoring Visits
• Simple processing and transport of laboratory samples
• Other duties as assigned or required by the research project
• Work with project administrator for needed tasks
• Other Administrative duties as assigned

Supervision Received: This position reports directly to Faculty Principal Investigator.

Supervision Exercised: Supervision of junior coordinators. Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

Senior Level:

• CRC Governance Committee review and approval
• Bachelors 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 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Intermediate Level:

• 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) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.

Senior Level:

• 9+ years of direct related experience

Intermediate level:

• 6+ years of direct related experience

Work schedule is 8:30-4:30 in person for recruiting and meeting with teams. Some studies may require work outside of regular hours, and flexibility in daytime hours will be considered if this is the case. For days with no in person recruitment duties, work from home can be considered with proper pre-planning and approvals.

This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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.

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 opportunity/affirmative action employer.