Senior IRB Coordinator - Office of Human Research Protections 14879
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 the 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 protections 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 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 protections 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 back up knowledge and experience is available at all times.
Other duties as assigned.
Bachelor's degree required. Master's preferred.
Five (5) years of experience in the following:
Strong knowledge and ability to apply all relevant federal, state, and university regulations, policies, and federal guidance documents. Thorough knowledge or demonstrated related experiences to comprehend, interpret, and apply complex regulations and legislation regarding the protection of human subjects including FDA, HIPAA, DHHS, OHRP as they relate to IRB operations, research and human subject protection.
Developing policies and procedures for a human subject research program.
Reviewing all types of human subject research leading to an in-depth working knowledge of all regulations, rules and policies applicable to human subject research.
Working with an IRB to gain insight into the roles of the IRB and the OHRP.
Clinical research monitoring and/or clinical research compliance experience highly desirable.
Experience working on the development and execution of clinical/biomedical research studies with principal investigators for human research subjects.
Strong project management experience desired.
Mastery of written and verbal communication.
Ability to utilize technology to conduct reviews and communicate with team, IRB members, researchers, students and others.
In-depth knowledge and understanding of how research is conducted, specifically in biomedical and social/behavioral sciences.
Strong computer skills, i.e. Microsoft family (Office 365, SharePoint, Teams, Outlook, Excel, PowerPoint, etc.) databases, electronic submissions (i.e.Kuali Coeus), video conferencing, etc.
Ability to develop and maintain good working relations with the members of the research community, while working remotely (if applicable).
Positive, professional attitude with high standards of integrity.
Must be a team player.
Professional certification in a field related to clinical research operations, healthcare research compliance or human subject protection awarded by groups such as Public Responsibility in Medicine and Research (PRIM&R), Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA), Health Care Compliance Association (HCCA) and/or other professional organizations of established size and credibility. PRIM&R CIP certification preferred.
At West Virginia University, we pride ourselves on a tireless endeavor for achievement. We are home to some of the most passionate, innovative minds in the country who push their limits for the sake of progress, constantly moving the world forward. Our students, faculty and staff make this institution one of the best out there, and we are proud to stand as one voice, one university, one WVU. Find out more about your opportunities as a Mountaineer at https://talentandculture.wvu.edu/
West Virginia University is proud to be an Equal Opportunity employer, and is the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff, and students, and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
Job Posting: May 26, 2020
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes
Internal Number: 205103
About West Virginia University
West Virginia University, founded in 1867, has a long and rich history as a public, land-grant institution. WVU encourages scholarship and offers high-quality academic programs while serving the state of West Virginia and the nation. WVU statewide includes campuses in Beckley, Charleston, Keyser, Martinsburg and Morgantown – which has been ranked as a #1 Small City in America. WVU is an R1 Doctoral Research University (Highest Research Activity), one of only 115 nationwide. WVU offers 212 degrees throughout the 14 colleges and schools. Areas of specialty include STEM education, healthcare in Appalachia, shale gas utilization, radio astronomy and forensics. WVU researchers have helped confirm the existence of gravitational waves and uncovered diesel vehicle emissions discrepancies. Statewide, there are over 31,000 graduate and undergraduate students along with 190,000 alumni worldwide. WVU is reinventing West Virginia’s future by strengthening education, healthcare and broad-based prosperity.