IRB Administrator - Human Research Protection Program 10641
The Department of Human Research Protection Program in the division of RES integrity and Compliance at West Virginia University is seeking applications for a IRB Administrator (MAP Title Program Coordinator). This position is responsible for reviewing human research protocols, assisting with policies and procedures, providing training and guidance to the research community daily and in the field as needed, and reviewing all research related events including non-compliance deviations, complaints and violations.
In order to be successful in this position, the ideal candidate will:
Pre-review and assign protocol submissions to the convened IRB meetings. Attend and record the discussion during meetings. Follow through with all materials during and after the IRB meetings.
Review and approve as needed human research protocols submitted that may fall under the exemption categories, Flex Model, or NHSR.
Schedule special meetings for urgent human research protections cases.
Review all research related events, which may include non-compliance, deviations, complaints 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.
Assist in maintaining AAHRPP accreditation including annual reports and renewals.
Review and coordinate review of human research protections policies and procedures for the Human Research Protection Program (HRPP). Update and modify policy and procedure documents as required.
Provide help and training to investigators, research coordinators, IRB members and any other groups within the institution.
Develop and maintain good working relations with members of the research community.
Update and develop training documents for members of the research community.
Schedule, attend and record minutes for the IRB chairs meetings, as needed.
Attend any exit interviews conducted by external auditors of human research, as needed.
Administratively arrange Quality Coordinator site visit of any type of research protocols, as needed. Will also pre-review the selected protocol prior to the site visit.
Assist others in the development of research protocols, amendments, continuing renewals, and other documentation in the Kuali Coeus (KC) electronic research administration system .
Bachelor's Degree is required.
Master's Degree is preferred.
Three (3) years of experience required:
Clinical research monitoring and/or clinical research compliance experience.
Working experience with federal and local regulations on human subject research.
Experience working on the development and execution of clinical/biomedical research studies with principal investigators for human research subjects.
Prefer experience with Kuali Coeus (KC).
Mastery of written and verbal communication.
An understanding of how research is conducted, specifically biomedical sciences and clinical research.
Computer skills, i.e. Microsoft family, databases, electronic submission, etc.
Ability to develop and maintain good working relations with the members of the research community.
High standards of integrity.
Must be a team player.
Requirements Requires a professional certification in a field related to clinical research operations, healthcare research compliance and 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.
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 http://hr.wvu.edu/ .
West Virginia University is an Equal Opportunity/Affirmative Action Employer and 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 individuals, including minorities, females, individuals with disabilities and veterans.
Job Posting: Mar 15, 2019
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes
Internal Number: 160740
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.