Department Description 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.
The OHRE now employs about 20 SPA and EPA staff reporting to a single Director. Working with 6 IRB Chairs and over 70 IRB members, OHRE staff share responsibility for educating the research community regarding federal regulations and IRB procedures, for processing all submissions, for maintaining accurate records of new and previously approved protocols, and for complying with all applicable regulations pertaining to research involving human subjects.
Position Description The Compliance Analyst is responsible for supporting Safety and Compliance functions in the Office of Human Research Ethics, including triaging and reviewing of New Safety Information, conducting fact-finding to prepare information for the Institutional review Board (IRB), evaluating Corrective and Preventative Action Plans, document decisions and controverted issues by the IRB, and independently compose memos and letters independently. The Compliance Analyst may also serve as primary or secondary reviewer and an alternate voting member of each of the IRBs. The Compliance Analyst will also contribute to the development of Standard Operating Procedures and guidance, participate in process improvement initiatives and represent the program in meetings and discussions. The person in this role will also serve as a subject matter expert on federal regulations and OHRE Standard Operating Procedures pertaining to Unanticipated Problems and Noncompliance for investigators, study teams, IRB Chairs, IRB personnel, and other relevant UNC offices.
Minimum Education and Experience Requirements Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Essential Skills, Knowledge and Abilities The ideal candidate must have the ability to exercise sound judgment and facilitate good and timely decisions that comport with the university objectives and federal regulations pertaining to human subjects research.
Preferred Qualifications The preferred applicant will have full knowledge of applicable federal regulations governing human subjects research (21 CFR 50 & 56; 45 CFR 46), including regulations pertaining to Unanticipated Problems Involving Subjects or Others, Serious and Continuing Noncompliance, and Suspensions and Terminations of Approval (45 CFR 46.108; 21 CFR 56.108) and Good Clinical Practice.
Application Types Accepted Applications must be received in the Department of Human Resources by the closing date to be considered. Please submit an online application for position number 00035876 at http://unc.peopleadmin.com/postings/176300
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
Internal Number: 152009
About University of North Carolina at Chapel Hill
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.