Duties: The IRB Administrator manages all administrative activities of the IRB. He/she is responsible for coordination of the initial and continuing review of protocols assigned to the IRB. This includes pre-reviewing submissions assigned to the convened IRB for completeness; pre-reviewing submissions eligible for expedited review; and working with researchers and research staff to resolve issues related to convened IRB or expedited IRB review. He/she prepares meeting agenda; assigns scientifically appropriate protocols to IRB members to review; attends convened meetings of the IRB; and maintains thorough and complete notes on the discussion. He/she prepares complete and accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research, and a written summary of controverted issues and their resolution. The IRB prepares written correspondence to investigators of all IRB actions and decisions. The IRB administrator reviews claims of exemptions and expedited reviews as assigned. He/she is the main source of contact between IRB Chair, IRB member/reviewers and investigators. He/she maintains minutes, IRB rosters, IRB hard copy and electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and IRB SOPs. In contacts with investigators the IRB administrator provides guidance on issues related to IRB regulations and IRB actions. The IRB Administrator participates, as assigned, in research community outreach and training activities; IRB member and administrative staff training; and IRB quality improvement initiatives including the review of existing IRB policies and procedures. He/she is responsible for the supervision of an administrative assistant including ongoing and yearly performance evaluations.
The IRB Analyst serves as reviewer for initial submissions to the IRB that may be eligible for exemption or expedited review, with a focus on studies that are social/behavioral in nature. This includes the review of submissions for completeness, eligibility for exempt or expedited level of review, and adherence to institutional policies, regulatory and ethical criteria for approval. He/she works closely with investigators during the review and approval process and advises researchers on regulatory and ethical standards as well as institutional policies and procedures; provides consultation to the research community on submission requirements; provides advice on preparation of IRB applications and associated documents for submission to the IRB.
Qualifications: A Bachelor's Degree and 3 years to 5 years of experience or equivalent combination of education and experience is required with at least 2-3 years of experience and knowledge directly related to regulatory review of research or equivalent combination of experience and education; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate: excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; and the ability to build and maintain positive working relationships at all levels of the institution. Certification as an IRB professional is highly desirable.
Reference Number: 83-26353
Salary Grade: 026
Employment Type: Exempt
Org: Institutional Review Board
Job Family: A-General/Professional Administrative