The Director, ORI is responsible for the oversight of the Institutional Review Board (IRB), Institutional Animal Care and Use (IACUC) Committee, Conflict of Interest in Research (COIR) Committee, Biosafety Committee, and Radiation Safety Committee.
Responsibilities include:
- Assisting the IRB coordinators in answering regulatory questions.
- Making determinations as to whether a study qualifies as human subject research.
- Conducting monthly record audits to ensure accuracy/completeness of IRB records and to conduct training if required.
- Processing studies in the absence of an IRB Coordinator or to help in times of an excess influx of submissions.
- Ensuring cross-training for the IRB Coordinators so that they are current with both the medical and social/behavioral regulation
- Working with the IRB Chairs to answer regulatory questions.
- Attending IRB meetings to provide regulatory oversight.
- Reviewing IRB minutes prepared by the IRB Coordinators for accuracy and completeness.
- Serve as the knowledgeable point of contact for any questions regarding the I RBNet submission system and to resolve any system issues or request changes.
- Work with the Research Director at the Veterans Administration Medical Center (VAMC) to address VA specific issues.
- Work with the Institutional Official (10) to review the effectiveness of the Human Research Protection Program (HRPP) and provide annual reports.
- Resolving issues of non-compliance.
- Serve as an Exempt reviewer.
- Conduct the Quality assurance and quality improvement program.
- Work with external IRBs in creating and submitting reliance agreements.
- Preparing annual reports for AAHRPP accreditation and serving as the coordinator for reaccreditation site visits.
- Ensuring FWA and IRB Registrations are up to date for MU and all affiliated institutions.
- Ensure the ORI website is current.
- Submitting required annual reports to regulatory agencies.
- Supervise FDA site visits and audits.
- Working with all the committees that fall under the ORI office.
Knowledge, Skills and Abilities:
- Must possess excellent problem-solving skills; good computer skills with a variety of applications; and the ability to speak to groups of people.
- Public speaking experience.
Location MURC - Marshall University Research Corporation Salary Range Salary is commensurate with experience and internal equity
Required Qualifications
Education
- Master’s degree or equivalent experience
Experience
- At least four years’ experience as an IRB administrator – i.e. experience interpreting federal, state and institutional regulations.
Preferred Qualifications
Education
- Certified IRB Professional (CIP) certificate or the ability to obtain a certification within 3 years.
Posting Detail Information
Posting Number MR0684 Open Date 02/12/2024 Close Date Open Until Filled Yes Special Instructions Summary