"Senior IRB Analyst"

Position Responsibilities

• Independently understands and applies the Federal Regulations for human research to all project applications submitted for category determination and each level of IRB review (pre-review, re-review, clarifying issues, post meeting, Non-committee review) to ensure adherence to regulatory and ethical standards.
• Acts as a liaison between the IRB and the research community and responds to queries regarding IRB submissions and IRB software.
• Independently conducts regulatory and administrative reviews of Exempt, Expedited and Full Board submissions.
• Provides engagement determinations.
• Serves as an IRB member.
• Independently oversees Board meeting, including making assignments to staff and Board members, obtaining quorum for the meeting and providing regulatory guidance at the meeting and writing minutes.
• Works with IRB leadership to review and update policies and procedures.
• Gives presentations to IRB staff, Board members and the research community.
• Serve as the administrator for one of the ancillary committees. Ancillary committees function as an added level of review, according to regulatory and/or institutional requirements, and are conducted on an as needed basis. This will involve acting as a liaison between the IRB, the research community, the Office of General Counsel or other entities as required; ensuring all additional requirements are fulfilled, before releasing approval. Supporting and educating and training board members in the review and approval of research subject to ancillary committee reviews. The administrator will also be involved in the oversight of the Committee functions, including writing and maintaining minutes and relevant policies.
• Provides mentorship and training, as needed, to other IRB analysts.
• Participates in regional and national conferences and educational events.
• Provides regulatory and ethical consults for investigators and research personnel on human subjects research related issues.
• Works with IRB leadership to develop and present educational initiatives for the research community on applicable IRB policies, procedures, federal and state regulations and ethical principles.

Qualifications

Bachelor's Degree and 3 or more years of direct IRB experience required. Equivalent combination of experience and education will be considered. Knowledge of applicable federal and state regulations (including 45 CFR 46, 21 CFR 50, 56, 312, 812) preferred. CIP required within a year, CCRP certification a plus.