Perform detailed administrative and regulatory review of applications for research with human subjects submitted to the IRB-HSBS via the eResearch Regulatory Management system.
Assess study protocols and accompanying documentation for completeness and clarity as well as for compliance with applicable regulations, guidelines, and policies.
Interpret and apply regulations, guidelines, and policies related to the conduct of research with human subjects.
Contact principal investigators to resolve inconsistencies and/or clarify information prior to IRB-HSBS review.
Respond to questions from investigators about the IRB application process and human subject protection regulations.
Prepare regulatory checklists and assign applications to reviewers.
Record IRB-HSBS decisions in eResearch and communicate regulatory determinations to principal investigators.
Participate in educational activities for the research community, including "IRB-on-the-Road."
May also include support for the convened IRB-HSBS boards, such as agenda preparation and dissemination, note-taking at board meetings, meeting setup, and other activities.
Special projects and other duties as assigned.