Research Compliance Specialist I

About the role

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.

Responsibilities

• Act as regulatory liaison for all clinical sites, coordinating centers, and data management centers.
• Assist with grant approval reviews and regulatory reviews.
• Coordinate investigator training sessions and assist with compliance investigations.
• Maintain databases and collaboratively assist with developing approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.
• Manage regulatory responsibilities for research efforts, including coordinating with study team members to prepare and submit IRB applications (study start-up, modifications, continuing reviews, and required reporting).
• 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.

Requirements

• Bachelor’s degree.
• Minimum of 1 year of relevant experience.
• Combination of education and relevant experience will be considered in lieu of education and/or experience requirement.

Skills

• FDA reporting experience is preferred but not required.

Physical Effort

• Requires some bending, stooping, and stretching.
• Walking around laboratory benches and various common laboratory rooms within the Division.
• Use of stairs often and may require multiple trips between common equipment rooms between floors.
• Normal range of hearing and eyesight to record, prepare, and communicate laboratory methods and results.
• Lifting up to 20 lbs.

Schedule

• Full-time, Monday–Friday, 8:30 am–5:00 pm.
• Occasional mornings, evenings, and weekends as needed.

Work Arrangement

On-campus: Teams that work on campus, in an office, or in a lab.