Rutgers, The State University of New Jersey, is seeking a IRB Manager for the Office for Research. The IRB Manager assumes a critical role in the research enterprise at Rutgers University. The primary responsibility is to ensure that all human subject research conducted under its auspices are carried out in such a manner that the rights and welfare of participants in research studies are protected and that Rutgers University complies with institutional, state and local, and federal regulations.
Among the key duties of this position are the following: •Reports to and works with the Assistant Director, IRB, overseeing the daily operations of the RU Institutional Review Board (IRB) office and serving as a liaison between the board and the research team. • Supervises staff assigned to provide administrative and regulatory support to the IRB. • Supervises IRB staff in regard to IRB policy, workflow efficiency, record-keeping, administrative issues, scheduling and earned time request, interaction with investigators, interpretation of human subjects’ regulations, management of IRB meetings and IRB member issues. • Assists the Assistant Director, IRB to oversee an internal quality assurance program with necessary reporting mechanisms and action plans for non-compliance, including monitoring QA audits and reviewing QA audit reports. • Leads the IRB Executive Committee, prepares agenda, minutes, and dissemination of items to appropriate entities within the University.
• Bachelor’s degree or an equivalent combination of education and/or experience. • A minimum of five (5) years of progressive experience in quality assurance, IRB operations or IRB/Reliance processes.
• Extensive knowledge of and proven experience with implementing federal and industry regulations that govern human subject research protections. • Current 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.
• 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. • 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. • Familiarity with HHS and FDA Federal Regulations pertaining to human subject research (45 CFR 46) and (21 CFR 50 and 21 CFR 56).
Internal Number: 21ST0246
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