Research Compliance Specialist II - 26006565

Research Compliance Specialist II Med-Neurological Surgery - Pennsylvania-Pittsburgh - (26006565) Job Summary Serves as regulatory liaison for all clinical sites, coordinating centers, and data management centers and performs grant approval reviews and assists with regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations. Essential Functions The University of Pittsburgh Department of Neurological Surgery is hiring a Research Compliance Specialist II. 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. IND preparation and 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. Serves as regulatory liaison for multiple clinical sites, coordinating centers, and data management centers for several research studies. Coordinates remote investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations. The University reserves the right to assign other duties to employees that are not listed in this job description. Minimum education to be considered for this position is a bachelor's degree in a related field. Interested candidates, please go to Home | Talent Center: Careers at Pitt | University of Pittsburgh and use requisition #26006565 to apply for this position. Physical Effort Lab - Requires some bending, stooping, and stretching. Walking around laboratory benches and various common laboratory rooms within the Division. The candidate will use stairs often and may have to View the full job description on the employer's website. Equal employment opportunity, including veterans and individuals with disabilities. PI287905230 / 11-9121.01 Clinical Research Coordinators