The IRB Regulatory Affairs Specialist will work as a part of the Institutional Review Board (IRB) team within the Office of Research Protections. The primary purpose of the IRB Regulatory Affairs Specialist is to develop, in compliance with applicable regulations and standards, policies and procedures and oversee reportable events respective to the conduct of research studies at the University of Pittsburgh and University of Pittsburgh Medical Center (UPMC}. Duties will include, but not be limited to:

Review reportable events submitted by investigators involved in research and use clinical knowledge to evaluate and recommend modifications to the protocol.Act as the Research Review Analyst (RRA) for Committee F of the IRB, and in preparation for Committee F, serve as a member of the Compliance Activity Review Subcommittee (CARS).Responsible for working closely with the IRB Chair or his designee on the review of Emergency Use Submissions and Protocol Exception Requests and for reviewing and processing final reports.Employee will participate in lectures, seminars, and other educational programs related to adverse event reporting for research studies.Serve as a Full Board Research Review Analyst as needed for committees other than Committee F.

Ensures that all federal regulations are adhered to and maintains up-to-date information regarding federal regulations and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents for research communities. Submits protocol reviews, verifies required documents, and handles complex issues.

Ensures that all federal regulations are adhered to and maintains up-to-date information regarding federal regulations and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents for research communities. Submits protocol reviews, verifies required documents, and handles complex issues.

Employee must have excellent communication and interpersonal skills. Organization and attention to details are crucial for this role.