University of Michigan · 7 hours ago
Research Compliance Spec Sr
Ann Arbor, MI
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expThe University of Michigan is seeking a Research Compliance Spec Sr to join their REMEDY team, which manages surgical clinical trials for the Department of Cardiac Surgery. This role involves overseeing study startup, amendments, closeouts, and ensuring compliance with regulations while training staff on relevant guidelines.
E-LearningEducationHigher EducationUniversities
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
University of Michigan
The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving, and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future.
10001+ employees
H1B Sponsorship
University of Michigan has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (662)
2024 (594)
2023 (787)
2022 (473)
2021 (411)
2020 (324)
Funding
Current Stage
Late StageTotal Funding
$359.75MKey Investors
Michigan Economic Development CorporationNational Institutes of HealthBreakthrough T1D
2025-07-17Grant· $1M
2025-06-07Grant· $1.17M
2025-04-23Grant
Leadership Team
Greg McGuire
Managing Director, Mcity
Robert Goodspeed
Chair, Urban and Regional Planning Program
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