The University of North Carolina at Chapel Hill · 3 weeks ago
Quality Assurance & Regulatory Specialist
North Carolina, United States
Full-time
Hybrid
Mid, Senior Level
$70K/yr - $85K/yr
3+ years expThe University of North Carolina at Chapel Hill is a global higher education leader in innovative teaching, research, and public service. The Quality Assurance & Regulatory Specialist will support Research Coordination & Management Unit clients by monitoring investigator-initiated trials and ensuring compliance with institutional policies and federal regulations.
EducationHigher EducationUniversities
Responsibilities
Supporting Research Coordination & Management Unit (RCMU) clients by monitoring investigator-initiated trials across the UNC research enterprise
Supporting the integrity, compliance, and quality of research conducted by the RCMU by developing, implementing, and maintaining quality assurance processes
Ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical Practice (GCP) standards
Serving as a resource for regulatory compliance, study documentation review, and best practice development contributing to a culture of continuous improvement and research excellence
Qualification
Required
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
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
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
Benefits
Professional training opportunities for career growth, skill development and lifelong learning
Exclusive perks for numerous retail, restaurant and performing arts discounts
Savings on local child care centers
Special rates on select campus events
Comprehensive benefits package
Paid leave
Variety of health, life and retirement plans
Additional programs that support a healthy work/life balance
Company
The University of North Carolina at Chapel Hill
Carolina’s vibrant people and programs attest to the University’s long-standing place among leaders in higher education since it was chartered in 1789 and opened its doors for students in 1795 as the nation’s first public university.
10001+ employees
H1B Sponsorship
The University of North Carolina at Chapel Hill has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (165)
2024 (143)
2023 (100)
2022 (133)
2021 (83)
2020 (89)
Funding
Current Stage
Late StageTotal Funding
$48.57MKey Investors
SECU FoundationCDA FoundationNorth Carolina Biotechnology Center
2024-07-19Grant· $1M
2024-03-18Grant
2023-02-16Grant· $0.11M
Leadership Team
Judith Cone
Retired Vice Chancellor for Innovation, Entrepreneurship and Innovation as of April 1, 2021
Michael Williams
Network SEcurity Team Lead
Recent News
Morningstar.com
2025-09-20
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