IRB Reliance 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.

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.

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.

* Understanding of the ethical considerations involved in human subject research.
* Familiarity with all applicable federal regulations (45 CFR 46 and 21 CFR 50 & 56), State and University policies, and the ability to identify and resolve any conflicting interpretation of those regulations.
* Comprehension of and facility with computer database systems.
* Attention to detail.
* Ability to perform multiple duties simultaneously and to manage occasional increased workload volumes.
* Ability to prioritize and process IRB Reliance Agreements in an expeditious manner.
* Independent decision-making while exercising good judgment.
* Exceptional oral and written communication skills; frequent telephone conversations with research faculty and staff, and University administrators.
* Ability to educate investigators and research coordinators regarding federal regulations and University policies governing research.

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 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.