IRB Reliance Manager

About the position

Responsibilities
• Lead and manage the negotiation, development, and execution of reliance agreements between the institution and external research entities.
• Ensure compliance with institutional policies and federal, state, and local regulations governing human subjects research.
• Maintain accurate and up-to-date documentation regarding all reliance agreements and related correspondence.
• Monitor the effectiveness and efficiency of reliance agreement processes and implement enhancements as needed.
• Stay informed about changes to regulations and best practices related to IRB reliance agreements.
• Provide supervision and guidance to the Senior IRB Analyst and consultative support to the University of Minnesota IRB.

Requirements
• Bachelor’s degree in a related field (e.g., health sciences, regulatory affairs, public health).
• Minimum of six years of experience in human subjects research administration.
• Comprehensive understanding of federal regulations (e.g., 45 CFR 46, FDA regulations) and ethical principles governing human subjects research.
• Strong communication, negotiation, and interpersonal skills.
• Excellent organizational skills and attention to detail.
• Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
• Proficiency in Microsoft Office Suite and other relevant software applications.

Nice-to-haves
• Advanced degree or JD strongly preferred.
• Certified IRB Professional (CIP) or similar credential.
• Five years of specific experience in IRB reliance administration.
• Experience with electronic IRB management systems (e.g., Click, IRBNet, iRIS).

Benefits
• Flexible work environment with options for remote work.
• Support for professional development and training opportunities.