Research Area Specialist Senior​/Intermediate

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A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

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.

The Department of Cardiac Surgery at Michigan Medicine is seeking a Research Area Specialist to serve as a subject matter expert and central resource for its broad clinical and outcomes research enterprise. This role supports the full lifecycle of research studies, offering strategic and operational partnership from study conception through closeout, while ensuring alignment with University, sponsor, and federal requirements. In close collaboration with investigators, research teams, administrators, staff, students, and institutional partners, the Research Area Specialist provides guidance and support on study design, protocol development, regulatory affairs, research applications, data governance, investigator-initiated studies, and daily research operations.

This individual will serve as an advisor, identifying opportunities to improve processes, navigating moderate to complex challenges, and promoting the quality and integrity of research practices across the department. The successful candidate will be expected to apply sound judgment and foster collaborative relationships with stakeholders at all levels.

Research Consultation and Study Development

• Serve as the department's primary resource for the planning, development, implementation, and administration of clinical and outcomes research studies.
• Consult with faculty investigators, fellows, residents, and research personnel regarding study design, methodology, feasibility, and implementation strategies.
• Provide guidance throughout the research study lifecycle, including study startup, conduct, amendments, continuing review, and study closure.
• Assist investigators with protocol development, protocol amendments, investigator-initiated studies, and research documentation.
• Support proposal development, budget preparation, and administrative requirements associated with sponsored and investigator-initiated research.
• Identify operational challenges affecting research studies and develop practical solutions to improve efficiency, quality, and compliance.

Regulatory Affairs and Research Compliance

• Coordinate regulatory activities for research studies, including preparation, submission, and management of IRB applications, protocol amendments, continuing reviews, and study closures.
• Conduct departmental pre-reviews of research submissions to ensure completeness and compliance prior to institutional review.
• Provide guidance regarding applicable federal regulations, institutional policies, Good Clinical Practice (GCP), and ethical standards governing research.
• Coordinate submission and management of Data Use Agreements (DUAs), Unfunded Agreements (UFAs), Memoranda of Understanding (MOUs), and other…