UNC-CH University of North Carolina at Chapel Hill
Location: Chapel Hill , North Carolina
Type: Full Time
Preferred Education: BSN
College / University
Telecommuting is allowed.
Internal Number: 01004042
The Office of Human Research Ethics (OHRE) is responsible for ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects. OHRE administers, supports, guides and oversees the work of the Institutional Review Boards (IRBs), and all related activities. These IRBs are federally mandated review committees, operating under regulations from the Office for Human Research Protections (OHRP, DHHS) and the Food and Drug Administration (FDA). The OHRE and IRBs are critical components of a program that serves to protect the rights and welfare of human research subjects. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements.
Additionally, in accordance with the mission of OHRE, the goals are to ensure compliance with federal regulations and university policy, and to promote best practices in human research protections. This can best be accomplished by consistent application of policies and procedures and standardized documentation of IRB actions.
This position is responsible for oversight, management and support of operational issues within the Office of Human Research Ethics (OHRE).
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.
Ability to communicate effectively in both writing and orally, inside and outside the University. This includes interactions that will represent UNC-CH nationally, as well as internal interactions with other administrators and researchers.
At least five years’ experience with Institutional Review Boards, preferably in a senior managerial capacity. Working knowledge of the federal regulations that govern research involving human subjects, including FDA (21 CFR 50 and 56), HHS (45 CFR 46) and HIPAA (45 CFR 160 and 164). Familiarity with international standards for human research is desirable. Experience conducting training for a broad group of stakeholders, including; researchers, study personnel, OHRE staff, and IRB members. Experience conducting both day-to-day and large scale quality improvement projects with a performance driven outcome.
About UNC-CH University of North Carolina at Chapel Hill
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 ...centralize 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.