POSITION INFORMATION: Provides administrative support to the Institutional Review Board (IRB) by assisting with submission and review coordination. Provides technical assistance to investigators involved in human subjects research.
Submission Assistance - Assists investigators with the application submission process. Interprets and advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements. Answers various questions and may guide investigators through some processes.
Application Screening - Screens research study applications to determine completeness and accuracy. Determines if studies meet review criteria for exempt, expedited, or full board by reviewing the IRB application, protocol and consent forms, ensuring they receive appropriate review according to federal regulations. Screens revised applications and resubmission's, reviews changes, and if acceptable, forwards to IRB Chairperson for final review.
Administrative Assistance - Assigns exempt and expedited studies to IRB Chairperson for review. Coordinates with principal investigators for preparation of material for board meetings. Generates correspondence on behalf of Director, Assistant Director, and/or IRB Chairpersons. Stamps study documents appropriately. Distributes correspondence to Investigators.
Review Coordination - Act as a liaison between the IRB, the IRB Chairperson, Investigators, Office of Research Administration (ORA), Radiation Safety Office and the Institutional Bio-safety Committee. Responsible for following up with investigators to ensure they are aware of time limits and deadlines. Coordinates and schedules monthly reviews and annual review reports with the IRB.
Meeting Coordination - Coordinates meetings for the Institutional Review Boards. Creates agenda, and ensures there is an appropriate composition of members to make quorum according to federal regulations. Ensures proper procedures are followed. Creates board letters with instructions for corrections based on deliberations at the meeting. Takes minutes, prepares written draft, and distributes to the IRB Chairperson as required.
Process Improvement - Makes recommendations for streamlining IRB review process such as the revision of applications and consent forms, investigator notification, prior categorization and assignment of application submitted for board review.
As Needed - Performs duties as needed to successfully fulfill the function of the position.
Education: Bachelor's Degree in a business related field
months experience in any combination of the following areas: IRB
administration, grant and contract administration, clinical and/or laboratory
research experience, communication or education fields
Equivalent/Substitution: 48 months experience may be substituted for the Bachelor's Degree for a total
of 60 months experience