Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist

Location: Hybrid, but primarily work from home

Duration: 6 month contract to hire

Responsibilities:

• Review all IRB and/or IACUC submissions to verify the required documents include all necessary information to make regulatory decisions.
• Verify that investigators and research staff possesses the appropriate education and experience (including IRB and/or IACUC required training) to conduct human or animal research.
• Assist the Research Quality Improvement Specialist in monitoring of BRI-sponsored clinical research according to Federal Guidelines and Good Clinical Practice (GCP) by participating in the monitoring visits for verification.
• Keep current on all developments and changes in federal and state regulations and requirements impacting human subject research and animal research in order to serve as a resource to IRB members.
• Provide regulatory guidance to PI's and Research Staff to support the successful submission of regulatory compliant materials that are approved by the IRB or IACUC as applicable.
• Assist in the implementation of a comprehensive education and training program for IRB members, IACUC members, Investigators, and Research Staff. This includes development of presentation regarding regulatory issues, tip sheets, regulatory updates, curriculum, BLN modules and other training opportunities.

Minimum Requirements:

• Bachelor's or 4 years of work experience above the minimum qualifications
• 2 years of experience