IRB Compliance Analyst

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

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.

The Compliance Analyst is responsible for Compliance functions in the Office of Human Research Ethics ( OHRE), including (1) triage and review of Promptly Reportable Information ( PRI), (2) conducting fact-finding to prepare information for the Institutional Review Board ( IRB), evaluating Corrective and Preventative Action plans, (4) documenting decisions and controverted issues by the IRB, (5) collaborating with partner UNC offices that contribute to reviews of compliance events, (6) monitoring the execution of compliance-related tasks, and (7) 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.

The Analyst will also be responsible for assigned aspects of the AAHRPP re-accreditation process.

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 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.

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),Good Clinical Practice, HIPAA Privacy Rule.

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.