University of North Carolina at Chapel Hill
Quality Assurance & Regulatory Specialist
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27517
General 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
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, a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience may be substituted. 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 clinical trial monitoring or auditing experience.
At least 2 years UNC research experience.
Experience in varied clinical areas.
Campus Security Authority Responsibilities Not Applicable.
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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
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, a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience may be substituted. 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 clinical trial monitoring or auditing experience.
At least 2 years UNC research experience.
Experience in varied clinical areas.
Campus Security Authority Responsibilities Not Applicable.
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