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.
Qualifications: BA/BS in a relevant discipline (biological sciences preferred); 2-3 years of experience or equivalent combination of experience and education (typical experience might include ethics, clinical trial performance, or experience in an academic IRB); detailed knowledge of applicable regulations related to the IRB; demonstrated management skills or experience; 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: 83-25091
Salary Grade: 026
Employment Type: Exempt
Org: Institutional Review Board
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: A-General/Professional Administrative