Clinical Research Coord Inter-TERM LIMITED

The Clinical Research Coordinator will work alongside the Principal Investigator in the Department of Family Medicine and a team of investigators across U-M and another institution to oversee a multi-site federally-funded R01 that will develop an online maternal health toolkit. The Clinical Research Coordinator will support study-related activities and help oversee project staff and milestones. This position contributes to the development of key processes, procedures to enhance the project’s clinical research activities and to ensure quality assurance for all study procedures, data collected, and regulatory reporting. Responsibilities may also include contributing to scientific abstracts, manuscripts, and research products and coordinating the dissemination of research direction and results with key community and clinical stakeholders and an advisory board. It also involves supervision of research assistant staff working on the project. The Principal Investigator and supervisor for this position is Dr. Kimberly McKee, an Assistant Professor in the Department of Family Medicine.

This position is part-time, 20 hours per week, and is term-limited based on available grant funding through 08/2030, with potential for extension based on funding availability.

• Develop protocols and procedures for study tasks, in collaboration with the research team.
• Develop informed consent documents and be responsible for IRB submissions, amendments, renewals, ORIOs, etc. and for regulatory compliance for the project.
• Communicate with research team members and community advisory group for the project and coordinate study logistics and multi-site meetings
• Support the principal investigator with compliance and reporting to funding and regulatory agencies (e.g., NIH, IRB), including but not limited to drafting Research Performance Progress Reports (RPPRs) and protocols.
• Supervise the research assistants on the study and assist Dr. McKee with performance evaluations and professional development of research staff
• Coordinate, schedule, and document study-related meetings, including coordination of multi-site team meetings with Dr. McKee’s U-M based research team
• Support activities and process that guide the research team’s professional development of its staff
• Develop and guide all clinical study operations
• Engage and network with key maternal health stakeholders – including community advisory member organizations, colleagues in the Department of Family Medicine, and colleagues in other departments and institutions – throughout the project period.
• Contribute to the design and development of the project’s obstetrical toolkit and study informatics, oversee adherence to all institutional and legal requirements, and coordinate dissemination to key stakeholders
• Design and lead recruitment and data collection efforts. This will include supervising the study research assistants, scheduling clinician interviews and American Sign Language (ASL) interpreters as needed, and coordinating with the partnering study site team.
• Develop procedures for ensuring quality assurance of all project related activities, data collection, and regulatory reports.
• Guide procedures that ensure the highest ethical standards and protections of research participants are maintained at all times.
• Serve as the team lead for research-related procurement and expense reporting
• Design procedures for monitoring and keeping the research team informed of study progress, including recruitment, enrollment, data collection, institutional approvals, and budgets.
• Demonstrate independence while work collaboratively with other team members.
• Support the scientific aims of the project by contributing as a co-author on scientific posters, presentations, and manuscripts with principal investigator and study team.
• Provide programmatic and administrative guidance as needed to any of Dr. McKee’s student workers or student volunteers on the project under her scientific mentorship.
• Support and lead the coordination of annual team-wide site-visits.

Supervision Received: Faculty Principal Investigator.

Supervision Exercised: Supervise research assistants on the study and assist Dr. McKee with performance evaluations and professional development of research staff

Requirements:

• 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 within six months of date of hire.
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.
• 6+ years of direct related experience

This is a term-limited appointment ending on 08/2030.