The Office of Human Research Protections at West Virginia University has an opportunity for a Senior IRB Coordinator who is responsible for reviewing IRB protocols and supporting IRB boards as well as maintaining AAHRPP accreditation and providing guidance to staff, board members, and the WVU research community.

In order to be successful in this position, the ideal candidate will:

• Pre-review and assign more than minimal risk protocols to the convened IRB meetings. Attend and record the discussion during meetings. Follow through with all materials during and after the IRB meetings.
• Schedule special meetings for urgent human research protection cases.
• Backup pre-review and assign any submission regardless of review type. Approve exempt, NHSR, and Flex submissions when needed. Complete follow through.
• Review all unanticipated events, which may include non-compliance, deviations, and violations by researchers and forward to the IRB for possible action.
• Assist in the development of new policies and procedures for the conduct of human subject research protections, particularly in regard to application for AAHRPP reaccreditation.
• Maintain AAHRPP accreditation annual reports and renewals.
• Review and coordinate review of human research protection policies and procedures for the WVU Office of Human Research Protections. Update and modify policy and procedure documents as required.
• Provide help and training (when requested) to investigators, research coordinators, IRB members, and any other groups within the institution.
• Update and develop training documents for members of the research community, IRB Committee members, and IRB staff.
• Provide guidance to IRB chairs and IRB members regarding federal and local regulations, including regulations that govern VA Medical Center for the conduct of human subject research.
• Liaison to the Louis A. Johnson VA Medical Center and other affiliate organizations regarding submission of protocols and related documentation for IRB approval.
• Schedule, attend, and record minutes for the IRB chairs meetings, as needed.
• Work closely with federal regulatory auditors regarding human research subject protections.
• Attend any exit interviews conducted by external auditors of human research, as needed.
• Maintain signature authority to approve minor amendments to research protocols, as well as signature authority to approve all reviewed research.
• Administratively arrange Quality Improvement Program (QIP) site visits of any type of research protocols. Pre-review the selected protocol prior to the site visit. Conduct QIP site visits with QIP consultant, as needed.
• Be familiar with and assist others in the development of research protocols, amendments, continuing renewals, and other documentation in the Kuali Coeus electronic research administration system.
• Be familiar with and assist others with multisite, collaborative study submissions including those using commercial IRBs, Smart IRB, IRBExchange, and other sIRB platforms.
• Conduct in-depth training of IRB staff to ensure appropriate backup knowledge and experience is available at all times.
• Other duties as assigned.