Job: Institutional Review Board (IRB) Administrative Coordinator

The Wheaton Franciscan Healthcare Institutional Review Board (IRB) reviews research conducted in Southeast Wisconsin and Iowa. The IRB Administrative Coordinator provides administrative support to the IRB by assisting with submission and review coordination. Provides technical assistance to investigators involved in human subjects research. Provides recommendations for improving the IRB review process. Submission Assistance. Assists investigators and research coordinators 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 resubmissions, reviews changes, and if acceptable, forwards to IRB Chairperson/Designee for final approval. Review Coordination. Act as a liaison between the IRB, the IRB Chairperson, Investigators and Office of Research Management. Responsible for following up with investigators to ensure they are aware of time limits and deadlines. Coordinates and schedules monthly reviews and continuing review reports with the IRB. Meeting Coordination. Coordinates meetings for the Institutional Review Board. 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 revisions based on deliberations at the meeting. Takes minutes and prepares a written draft, as required. Process Improvement. Makes recommendations for streamlining IRB review process. For example, suggesting revision of reviewer checklists, application forms, consent forms, and investigator notifications.

Must have excellent written and communication skills.Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred. Bachelors Degree required