Michigan Medicine · 18 hours ago
Research Compliance Spec Sr
Ann Arbor, MI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expMichigan Medicine is part of the University of Michigan, focusing on surgical clinical trials for the Department of Cardiac Surgery. The role involves managing study start-up, compliance audits, and regulatory documentation for clinical trials.
EducationHealth CareMedical
Responsibilities
Responsible for study start up for all clinical trials (FDA regulated and non-FDA regulated), including but not limited to: managing CDA in eRPM, feasibility, scheduling/attending site qualification visit, intake, coordinating with the CTSU, completing IRB application(s), V AC committee approval, requesting CDMs, approving billings grids and budgets, collecting regulatory/training documents, and scheduling SIVs
Processes study amendments, including reviewing protocol, updating budget, coordinating with the CTSU Amendment team, collecting training documents, updating regulatory binder/shared drive, and submitting IRB amendment
Completes study close out, including but not limited to: IRB termination, close out of delegation log, financial reconciliation
Performs internal audits to ensure study compliance and contributes to corrective and preventative action (CAPA) plans
Oversees regulatory documentation for quality assurance
Develops SOPs that adapt any established procedures, processes, or workflows to reflect any new or updated regulations and ensures adherence
Invoices for department managed clinical studies
Assists with preparation for and attends study monitoring visits and external audits
Trains staff on state, federal, local, and institutional regulations to ensure compliance
Qualification
Required
Bachelor's degree or an equivalent combination of related education and experience is necessary
Experience in human subjects research compliance
Preferred
Minimum 8 years of professional experience in research compliance oversight and/or research experience with biomedical research
Company
Michigan Medicine
Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Ascani
Director, Business Operations - Applied Systems Biology Core
Jack Kufahl
Chief Information Security Officer
Recent News
2025-12-11
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