JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Institutional Review Board (IRB) Reliance Manager is responsible for managing the reliance process and relationships between the University of Tennessee Health Science Center (UTHSC) IRB and outside/external IRBs, including institutional and commercial IRBs. This position works with the IRB Director and Associate Director to develop policies, guidelines, and procedures related to the reliance agreement process; serves as key liaison between the UTHSC IRB, researchers, clinical study sites, external organizations and IRBs regarding IRB reliance issues. The Reliance Manager works with the Office of Sponsored Programs and the Contracts offices of UTHSC affiliate institutions to address legal and institutional requirements related to reliance agreements and the reliance process. This position provides back-up support for IRB Specialists.
DUTIES AND RESPONSIBILITIES:
Responsible for analytical and administrative review and issuing approval of studies being conducted under IRB reliance agreements.
Advises and ensures that UTHSC institutional requirements for human subjects research, and ancillary reviews such as IBC and radiation safety committee reviews, are completed and relevant information provided to reviewing IRB.
Reviews registration of study and related documents in iMedRIS, ensures the local investigator has submitted required information, and ensures UTHSC-required information is incorporated into the local consent forms approved by the reviewing IRBs.
Reviews application and related documents submitted by relying sites to assure that required information has been submitted.
Interprets and applies federal and state regulations, and institutional policies, relevant to human research and privacy. These include DHHS, FDA, and HIPAA research related regulations and policies as well as requirements of UTHSC and other institutions covered by the UTHSC IRB.
Completes comprehensive reviews of IRB post-approval, identifies regulatory issues as well as institutional policy issues, and makes recommendations.
Communicates concerns to research staff (investigators and/or coordinators) with the goal of resolving pertinent issues and approves administrative and procedural modifications.
Advises and provides guidance to researchers to facilitate the use of IRB Authorization Agreements.
Reviews and manages requests from researchers to rely on an external IRB
Reviews and manages requests from external organizations/investigators to rely on the UTHSC IRB
Serves as liaison with reviewing IRB for IRB and study-related matters including questions related to institutional and local context. Acts as liaison with the Office of Sponsored Programs, the Contracts offices of UTHSC affiliate institutions, and external IRBs to coordinate the finalization and execution of Reliance Agreements.
Develops and implements training/educational materials for the research community regarding the use of IRB reliance agreements.
Performs other related duties as assigned.
Internal Number: 212606
The mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care, and public service.