This position is part of UNC-CH’s Office of Human Research Ethics (OHRE) reliance team and works under the supervision of the IRB Reliance Manager and the Associate Director of Regulatory Affairs and Compliance.
The IRB Reliance Analyst serves as an expert consultant on the Reliance Processes. This position is responsible for processing and reviewing submissions where study teams request to rely on external institutions or IRB’s and reviewing requests for external institutions or investigators to rely on UNC.
This position supports the Reliance Team with developing and updating outward and inward facing guidance materials on Reliance.
In addition, the IRB Reliance Analyst interacts directly with investigators, study staff, and relevant University offices (e.g. Office of University Council, Office of Sponsored Research, Office of Clinical Trials, Conflict of Interest Office) as needed.
Prior experience in research, research administration, and/or regulatory affairs is highly desirable, with preference given to those candidates possessing IRB experience. Knowledge of complex medical concepts and terminology is important. Reading knowledge of Spanish/other foreign languages is a desirable plus.
The OFFICE OF HUMAN RESEARCH ETHICS (OHRE) administers, supports and oversees the work of the Institutional Review Boards (IRBs) and all related activities at UNC-Chapel Hill. Any research project involving human subjects proposed by a member of the faculty, a post-doc, a staff member or a student at UNC-Chapel Hill must be reviewed and approved by an IRB before that research may begin, and before related grants may be funded. These IRBs are federally mandated review committees, operating under regulations promulgated by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA). The IRBs and OHRE are critical components of a program that serves to protect the rights and welfare of more than one million human research subjects who take part in more than 5000 different research projects each year at UNC-Chapel Hill. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements.The OHRE was established in 2003, reporting to the Vice Chancellor for Research. It was created to cent...ralize what had been a highly decentralized human research protection system, an action necessary to secure accreditation for the program. In 2006 the OHRE received full accreditation from the Association for the Accreditation of Human Research Protection Programs and has been fully accredited ever since.
