Rutgers, The State University of New Jersey, is seeking a IRB Reliance Manager for Research Regulatory Affairs. As part of the Office for Research, the IRB Reliance Manager assists in the implementation and day-to day regulatory operations of single IRB and reliance agreement process (IRB reliance requests, local context review of applicable IRB submissions and commercial IRBs). The position manages interactions with research community, develops and implements SOPs in support of the Rutgers University IRB Office and Human Research Protection Program.
Among the key duties of this position are the following: • Reviews and manages IRB reliance requests. • Exercises independent judgement in review and management of IRB Reliance Agreements and Independent Investigator Agreements, including the review of newly proposed agreements and associated documentation when determining reliance. • Coordinates with the Assistant Director of Reliance to ensure that proposed reliance and the terms of agreements are acceptable to the RU IRB. • Facilitates and/or conducts local context review of applicable IRB submissions, including regulatory pre-reviews of human research studies to ensure regulatory and institutional compliance. • Works closely with IRB members to address local context concerns. • Develops materials and processes to support researchers, IRB members, and staff compliance with the terms of reliance agreements.
• Extensive knowledge of and proven experience with implementing federal and industry regulations that govern human subject research protections. • Must have a current and working knowledge of federal, state, and local regulations and institutional policy and procedures to ensure the RU IRBs and HSPP are in compliance with applicable mandates. • Requires excellent communication skills (both verbal and written), strong problem solving and decision-making skills and the ability to make decisions independently. • Ability to take initiative and simultaneously manage multiple projects with minimal supervision. • Highly organized and able to prioritize and handle multiple tasks simultaneously. • Use of personal vehicle in order to travel for business demands; a valid driver’s license would be required for this position.
• Master’s or other advanced degrees, protocol writing and/or document review, and grant proposal congruence review. • Certified IRB Manager (CIM) OR Certified IRB Professional (CIP) is preferred.
Internal Number: 21ST0284
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