Quality Assurance & Regulatory Specialist

University of North Carolina - Chapel Hill

$70,000 - $85,000

United States, North Carolina, Chapel Hill

104 Airport Dr (Show on map)

Jan 05, 2026

Posting Information

Department	TraCS Institute-429801
Career Area	Research Professionals
Posting Open Date	01/05/2026
Application Deadline	01/20/2026
Open Until Filled	No
Position Type	Permanent Staff (EHRA NF)
Working Title	Quality Assurance & Regulatory Specialist
Appointment Type	EHRA Non-Faculty
Position Number	20074234
Vacancy ID	NF0009467
Full Time/Part Time	Full-Time Permanent
FTE	1
Hours per week	40
Position Location	North Carolina, US
Hiring Range	$70,000 - $85,000
Proposed Start Date	02/02/2026

Position Information

Be a Tar Heel!	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.
Primary Purpose of Organizational Unit	Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research. Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond. Education: We prepare tomorrow's healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce. Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.
Position Summary	Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit's business needs. The Quality Assurance & Regulatory Specialist will be responsible for supporting Research Coordination & Management Unit ( RCMU) clients by monitoring investigator-initiated trials across the UNC research enterprise. This position will also support the integrity, compliance, and quality of research conducted by the RCMU by developing, implementing, and maintaining quality assurance processes. The Quality Assurance & Regulatory Specialist plays a key role in ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical Practice ( GCP) standards. The selected candidate will serve as a resource for regulatory compliance, study documentation review, and best practice development contributing to a culture of continuous improvement and research excellence.
Minimum Education and Experience Requirements	Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.
Required Qualifications, Competencies, and Experience	In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) guidelines. At least 2 years of clinical trials experience. Comfort interacting with internal and external stakeholders and the ability to successfully collaborate with multidisciplinary groups of colleagues. Excellent customer service skills and good judgement are required. Ability to multitask and work independently with guidance from supervisor. Strong organizational and problem-solving skills. Must have a demonstrated ability to deliver high quality results on time and to manage competing priorities. Clinical trials and/or monitoring experience. Strong software and computer skills.
Preferred Qualifications, Competencies, and Experience	SOCRA or ACRP certification preferred. At least 5 years clinical trials experience. At least 3 years of clinical trial monitoring or auditing experience. At least 2 years of UNC research experience. Experience in varied clinical areas.
Special Physical/Mental Requirements
Campus Security Authority Responsibilities	Not Applicable.
Special Instructions
Quick Link	https://unc.peopleadmin.com/postings/311349

Posting Contact Information

Department Contact Name and Title	Stephanie Fleming, HR Consultant
Department Contact Telephone or Email	stephanie_fleming@med.unc.edu
Office of Human Resources Contact Information	If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.
Equal Opportunity Employer Statement	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.