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Institutional Review Board (IRB) Regulatory Analyst, Part-Time, 2nd Available Position

Wayne State University · Detroit, MI, US

Imported listingfull-time21 days ago

About The Role

The Institutional Review Board (IRB) Administration Office is responsible for ensuring Wayne State University (WSU) and WSU affiliate human participant research activities comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. The IRB Regulatory Analyst is responsible for providing expert analysis and conducting reviews of minimal-risk research submissions, including expedited amendments, expedited continuing reviews, and minimal risk initial submissions to ensure compliance with federal regulations, institutional policies, and ethical standards for the protection of research participants. This position evaluates submission materials for completeness, accuracy, and regulatory appropriateness; communicates with IRB Administration Office support staff, investigators, and study teams to resolve review issues; and helps facilitate timely, consistent, and well-documented determinations. This position reports to the Director, Human Research Protection Program (HRPP). Essential Functions : Conduct expert regulatory and institutional review and analysis of minimal-risk research submissions, including initial minimal risk submissions, expedited amendments, and expedited continuing reviews. Evaluate IRB submission materials for completeness, accuracy, consistency, and regulatory appropriateness; identify needed revisions or clarifications. Communicate with IRB Administration staff, investigators, and study teams to resolve review issues and provide guidance regarding IRB requirements. Prepare and maintain accurate review of documentation, determinations, correspondence, and records to support timely and consistent IRB decisions. Support compliance with federal regulations, institutional policies, ethical standards, and accreditation requirements through consistent application of IRB procedures. Maintain current knowledge of human participant protection requirements. Perform other duties as assigned.

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