Research Compliance Specialist I

Research Compliance Specialist I

Assists to serve as regulatory liaison for all clinical sites, coordinating centers, and data management centers and assists with grant approval reviews and regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and collaboratively assists with developing approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.

The University of Pittsburgh Department of Neurological Surgery is hiring a Research Compliance Specialist I. This position will be responsible for regulatory duties for neurological surgery research studies and assist as needed with study coordination, not as primary coordinator. Manage regulatory responsibilities for research efforts in the Department of Neurosurgery, including coordinating with study team members to prepare and submit IRB applications (study start-up, modifications, continuing reviews, and required reporting). Maintain well-organized regulatory documentation to ensure compliance with institutional and federal guidelines. FDA reporting experience is preferred but not required. Collaborate with external sites to obtain regulatory approvals and support the management of regulatory files for multisite sIRB studies. Assist other study staff with duties related to overall study execution to ensure efficient and compliant project operations.