Assistant Director, Clinical Trials Quality Assurance Program

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.

Research Compliance Services ( RCS) supports the Office of the Vice Chancellor for Research ( OVCR). RCS enables and protects UNC-Chapel Hill`s $1 billion research enterprise by ensuring adherence to applicable regulations, policies, and ethical standards. In alignment with the OVCR`s mission to grow and support research through strategic leadership, infrastructure development, and external engagement, our unit provides essential oversight and guidance to facilitate compliant research practices. By working collaboratively with researchers and administrative units, we help mitigate risk, promote integrity, and uphold the standards necessary to advance the University`s varied and interdisciplinary research portfolio.

INTERNAL ONLY: Internal posting for permanent, time-limited and layoff priority employees of UNC-Chapel Hill only.

This position may be eligible for a hybrid work arrangement that may include a partially remote work location, consistent with System Office policy. UNC Chapel Hill employees are generally required to reside within a reasonable commuting distance of their assigned duty station.

The Assistant Director for Clinical Trials Quality Assurance ( CTQA) Program will be responsible for designing and maintaining a program to audit clinical trial studies to ensure that they are being conducted pursuant to the terms and conditions of their Institutional Review Board approval, the sponsor or grant agreement, governing laws and regulations, good clinical practice, and UNC-CH policies and procedures. The position will report to the Director of the Clinical Research Compliance Office ( CRCO) but will be expected to have strong collegial relationships with administrators in the Office of Human Research Ethics ( OHRE), the Office of Sponsored Research, and the Office of Research Compliance, among others. A review methodology will be adopted that will establish goals and objectives such as the target number of reviews that will be carried out over the course of a year. In addition, the reviewer must be available to lead directed reviews that may be undertaken as a result of allegations of noncompliance or misconduct or in preparation for an examination inspection by a regulatory agent. The successful candidate will demonstrate a mastery of regulations promulgated by the Office of Human Research Protections, the Food and Drug Administration, the Public Health Service and National Institutes of Health, and others.

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.

INTERNAL ONLY: Internal posting for permanent, time-limited and layoff priority employees of UNC-Chapel Hill only.

* Substantial experience with clinical research administration
* Experience in university clinical research administration or closely related relevant experience
* Demonstrated familiarity with FDA and OHRP guidelines and regulations, as well as have knowledge of Good Clinical Practice ( GCP)
* Demonstrated ability to work effectively with faculty, staff, administrators, and the business community

* Master's degree in science or health/life sciences
* 5 years or more of university clinical research administration or closely related relevant experience
* Demonstrated strong communication skills
* ACRP or SOCRA certification

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.