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 bolthires 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. Apply tot his job Apply tot his job