Research Compliance Specialist II

About the role

The University of Pittsburgh Department of Neurological Surgery is hiring a Research Compliance Specialist II. This position is responsible for regulatory duties for neurological surgery research studies and assists as needed with study coordination, not as primary coordinator. The role serves as regulatory liaison for all clinical sites, coordinating centers, and data management centers, performs grant approval reviews, 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.

Responsibilities

• 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.
• 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.
• Serve as regulatory liaison for multiple clinical sites, coordinating centers, and data management centers for several research studies.
• Coordinate remote investigator training sessions, assist with compliance investigations, maintain databases, and develop approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.
• IND preparation and FDA reporting experience is preferred but not required.

Qualifications

• Bachelor's degree in a related field (minimum education required).
• Minimum 2 years of relevant experience.
• Combination of education and relevant experience will be considered in lieu of education and/or experience requirements.

Schedule

Full-time regular, Monday–Friday 8:30 am–5:00 pm, with occasional mornings, evenings, and weekends as needed. Work arrangement is on-campus.

Physical requirements

Laboratory environment requiring some bending, stooping, and stretching; walking around laboratory benches and various common laboratory rooms within the division; frequent use of stairs and multiple trips between common equipment rooms across floors. Normal range of hearing and eyesight required to record, prepare, and communicate laboratory methods and results. Lifting up to 20 lbs.

Additional information

Campus: Pittsburgh. Job family: Compliance & Audit; sub-family: Research Compliance. Assignment category: Full-time regular. Requisition #26006565. Background check required for finalists. Relocation not offered. Visa sponsorship not provided. Required document: resume.