Research Compliance Specialist I
About the role
This position will assist with regulatory duties for neurological surgery research studies and provide support as needed with study coordination. Key responsibilities include coordinating with study team members to prepare and submit Institutional Review Board (IRB) applications, maintaining regulatory documentation, collaborating with external sites to obtain regulatory approvals, and supporting the management of regulatory files for multisite Institutional Review Boards (IRBs).
Responsibilities
- Coordinate 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 IRB studies
- Absorb and assist with duties related to overall study execution to ensure efficient and compliant project operations
Requirements
The ideal candidate will have experience with regulatory processes, familiarity with federal and institutional guidelines, and the ability to manage multiple tasks efficiently.
Qualifications
- Bachelor's degree in a relevant field
- 1+ years of experience in regulatory affairs or research compliance
Skills
- Strong organizational and communication skills
- Ability to work independently and as part of a team
- Familiarity with regulatory requirements and compliance standards
Benefits
The University of Pittsburgh offers a comprehensive benefits package including health insurance, retirement plans, and paid time off.
Pay
To be determined based on qualifications.
Schedule
M-F 8:30am-5pm, occasional mornings, evenings, and weekends as needed.