The Compliance Analyst is responsible for compliance functions in the Office of Human Research Ethics (OHRE), including triage and review of Promptly Reportable Information (PRI), 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, liaise with partner UNC offices that contribute to reviews of compliance events, monitor the execution of compliance-related tasks, and independently compose memos and letters. The Compliance Analyst may also serve as primary or secondary reviewer and an alternate voting member for each of the IRBs.
The Compliance Analyst will ensure appropriate execution of OHRE Standard Operating Procedures (SOPs) and contribute to continual improvements to Compliance-related 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 SOPs pertaining to Unanticipated Problems and Noncompliance for investigators, study teams, IRB Chairs and members, OHRE personnel, and other relevant UNC departments, offices, centers, and institutions.
Responsible for assigned aspects of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) re-accreditation process.
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 postdoc, 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 UNC-Chapel Hills Human Research Protection Program (HRPP) that serves to protect the rights and welfare of more than one million human research subjects who take part in more than 6,000 different research projects each year at UNC-Chapel Hill. All components of the HRPP must work together to ensure institutional compliance with ethical principles and regulatory 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.
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.