PRIMARY DUTIES AND RESPONSIBILITIES:

1. Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (WUSTL/HRPO) policies and procedures. Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure. Research reviews will include new and continuing review of studies, modifications, etc.
2. Provide justification for expedited classification or refer the submission to the full board committee if expedited classification is found not to be appropriate.
3. Communicate with investigators (via telephone, myIRB and in person) to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any. Contingencies (requests for changes or clarifications) should include standard statements from myIRB manual, regulatory guidance and education as applicable. Communications must be clear, concise, and grammatically correct.
4. Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
5. Provide guidance to research coordinators and investigators regarding applications in preparation for submission to HRPO, via myIRB, SWAT on call and office hours.
6. Consult with other experts as needed to conduct informed, qualitative review of biomedical and behavioral research involving human participants. Experts may include physician-scientists or other clinical professionals, HRPO colleagues and scientists in the social-behavioral-educational sciences, HRPO and Institutional colleagues in research administration.

OTHER RESPONSIBILITIES:

1. Serve as a primary reviewer and voting member of a convened IRB.
2. Serve as a resource for other IRB members.
3. Perform educational presentations (formal and informal) to HRPO colleagues, to WU research community, and at national meetings of IRB professionals.
4. Participate in special projects, development of guidance documents, and/or quality assurance/improvement assessments.
5. Other duties as assigned.