The Institutional Review Board(IRB) Regulatory Specialist analyzes research protocol submissions to assurethat protocol procedures and the consent process are structured in a mannerthat meets the requirements of federal, state, and institutional regulationsand policies governing human research and privacy.
Interprets and applies federal and state regulations and policies, 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.
Provides regulatory, ethical, and method advice to individual faculty, staff, and students in preparation of applications for research proposals involving human subjects and consent documents.
Completes comprehensive reviews of extremely complicated scientific research documents; identify regulatory issues as well as institutional policy issues and make recommendations.
Communicates concerns to research staff (investigators and/or coordinators) to resolve pertinent issues and approval for administrative and procedural modifications.
Provides recommendations and assist with the design, testing and management of the IRB electronic system, iMedRIS; collaborate with department core users to enhance current electronic system.
Develops and provides orientation and training to IRB members in the electronic submission, review, and approval process.
Provides guidance and training to investigators and study coordinators regarding IRB submissions.
Assists in the evaluation of the IRB review process on an on-going basis, and propose process improvements.
Oversees and coordinates the preparation of new applications for IRB meetings; ensures that all relevant documents are provided and that the new applications are ready for review by the Board.
Attends all IRB meetings to explain to members regulatory issues regarding study applications and to clarify recommended changes.
Performs other duties as required.
Internal Number: 165465
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.