IRB Reliance and Post-Approval Monitoring Manager

Fairfax, VA
Commensurate with education and experience
Aug 05, 2022
Nov 02, 2022
Full Time
IRB Reliance and Post-Approval Monitoring ManagerThe George Mason University, Office of Research Integrity and Assurance (ORIA) seeks a highly motivated, well-qualified person to serve as the IRB Reliance and Post-Approval Monitoring Manager. This research support team nurtures and promotes state-of-the-art research and scholarship at Mason, providing resources that promote the ethical and responsible conduct of research. The team monitors and investigates instances of noncompliance, demonstrating the University's commitment to practice to the highest ethical standards in research and scholarship. George Mason University has a strong institutional commitment to the achievement of excellence and diversity among its faculty and staff, and strongly encourages candidates to apply who will enrich Mason's academic and culturally inclusive environment. About the Position: As part of ORIA, the Institutional Review Board (IRB) Compliance Manager for Reliance and Post-Approval Monitoring (the IRB Compliance Manager) is responsible for the implementation and day-to day regulatory operations of the single IRB and reliance agreement processes (IRB reliance requests, local context review of applicable IRB submissions and work with commercial IRBs) as well as the design and implementation of procedures for post-approval monitoring (PAM) of studies approved through the IRB. The IRB Compliance Manager will exercise substantial independence, authority and discretion in designing and performing post-approval monitoring activities and interpreting related Federal regulations and Mason policies, negotiating IRB reliance agreements, and conducting related outreach to Mason colleges and departments.Responsibilities:Provide strategic direction for the IRB post-approval monitoring program at Mason in collaboration with the AVPRI and the Vice President for Research including the following duties:Ensure ongoing human subjects research is conducted in accordance with IRB-approved protocols as well as existing regulations, policies and procedures;Perform routine educational and for-cause monitoring of human subjects research protocols to ensure the appropriate regulations were applied during the review of the study, the research/activity is being conducted as approved by the IRB, and to ensure adherence to local and federal post-approval requirements;Draft audit reports for monitoring and educational visits that provide a comprehensive evaluation of the findings of the visit and reflect any corrective and preventative action plans discussed with the study team and/or the IRB;Facilitate communication between the GMU IRB and researchers by developing educational materials and working collaboratively with researchers to improve understanding of and compliance with the GMU IRB post-approval requirements, policies and procedures; andAssist with the development and implementation of human subject protection policies and guidance pertaining to post-approval monitoring and education.Act as the primary point of contact for all studies involving single IRB review including the following duties:Review and manage IRB reliance requests (including reliance agreements facilitated through SMART IRB and other master agreements);Facilitate the reliance process by serving as a liaison between GMU's IRB, other institutions and their IRBs, and researchers regarding matters related to IRB reliance;Exercise independent judgement in review and management of IRB Reliance Agreements, including the review of newly proposed agreements and associated documentation when determining reliance;Coordinate with the IRB Director, IRB Chair, and Assistant Vice President of the Office of Research Integrity and Assurance to ensure that any proposed reliance and the terms of agreements are acceptable to the GMU IRB and to Mason;Facilitate and/or conduct local context review of applicable IRB submissions, including regulatory pre-reviews of human research studies to ensure regulatory and institutional compliance;Develop materials and processes to support Mason researchers, IRB members, and staff in order to establish compliance with the terms of reliance agreements;Assist with the development and implementation of human subject protection policies and guidance pertaining to multi-site research reviews and requirements; andAssist with IRB-related special projects and other duties as assigned.Required Qualifications:Master's degree or an equivalent combination of relevant education and experience;Considerable experience (generally 5+ years) in IRB operations and/or sIRB/Reliance processes;Demonstrated, effective communication skills, the ability to facilitate complex conversations about integrity and ethics;Extensive working knowledge of federal, state, and local regulations and institutional policy and procedures to ensure the GMU IRB and Human Subjects Research Program are in compliance with applicable mandates;Demonstrated, effective 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; andActive Certified IRB Professional (CIP).Preferred Qualifications:Experience supervising IRB staff; andExperience developing IRB policies and procedures.

For full consideration, applicants must apply for position number FA88CZ at please complete and submit the online application; and upload a cover letter, CV, and a list of three professional references with contact information.

"Great Careers Begin at Mason! George Mason University is an innovative, entrepreneurial institution with national distinction in both academics and research. Mason holds a top U.S. News and World Report "Up and Coming" spot for national universities and is recognized for its global appeal and excellence in higher education.Mason is currently the largest and most diverse university in Virginia with students and faculty from all 50 states and over 135 countries studying in over 200 degree programs at campuses in Arlington, Fairfax and Prince William, as well as at learning locations across the commonwealth. Rooted in Mason's diversity is a campus culture that is both rewarding and exciting, work that is meaningful, and opportunities to both collaborate and create.If you are interested in joining the Mason family take a look at our current opportunities and catch some Mason spirit at!George Mason University, Where Innovation is Tradition."

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