The University of North Carolina at Chapel Hill
Quality Assurance & Regulatory Specialist
The University of North Carolina at Chapel Hill, Raleigh, North Carolina, United States
Quality Assurance & Regulatory Specialist
Position Details
Full‑time permanent staff (EHRA NF), located in North Carolina, US. 40 hours per week, 1 FTE. Proposed start date: 02/02/2026. Hiring range: $70,000 - $85,000.
Position Summary The Quality Assurance & Regulatory Specialist will support Research Coordination & Management Unit (RCMU) clients by monitoring investigator‑initiated trials across the UNC research enterprise. Responsibilities include developing, implementing, and maintaining quality assurance processes; ensuring research activities adhere to institutional policies, federal regulations, and Good Clinical Practice (GCP) standards; and serving as a resource for regulatory compliance, study documentation review, and best practice development.
Minimum Education And Experience Requirements Relevant post‑baccalaureate degree required (or foreign degree equivalent). For candidates with comparable independent research productivity, a relevant bachelor’s degree (or foreign degree equivalent) with 3 or more years of relevant experience may be accepted. May require terminal degree and licensure.
Required Qualifications, Competencies, And Experience
In‑depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; GCP, FDA regulations, ICH guidelines.
At least 2 years of clinical trials experience.
Comfort interacting with internal and external stakeholders and ability to collaborate with multidisciplinary groups.
Excellent customer service skills and good judgement.
Ability to multitask and work independently with guidance from supervisor.
Strong organizational and problem‑solving skills.
Demonstrated ability to deliver high‑quality results on time and 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.
Special Physical/Mental Requirements None specified.
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.
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Position Summary The Quality Assurance & Regulatory Specialist will support Research Coordination & Management Unit (RCMU) clients by monitoring investigator‑initiated trials across the UNC research enterprise. Responsibilities include developing, implementing, and maintaining quality assurance processes; ensuring research activities adhere to institutional policies, federal regulations, and Good Clinical Practice (GCP) standards; and serving as a resource for regulatory compliance, study documentation review, and best practice development.
Minimum Education And Experience Requirements Relevant post‑baccalaureate degree required (or foreign degree equivalent). For candidates with comparable independent research productivity, a relevant bachelor’s degree (or foreign degree equivalent) with 3 or more years of relevant experience may be accepted. May require terminal degree and licensure.
Required Qualifications, Competencies, And Experience
In‑depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; GCP, FDA regulations, ICH guidelines.
At least 2 years of clinical trials experience.
Comfort interacting with internal and external stakeholders and ability to collaborate with multidisciplinary groups.
Excellent customer service skills and good judgement.
Ability to multitask and work independently with guidance from supervisor.
Strong organizational and problem‑solving skills.
Demonstrated ability to deliver high‑quality results on time and 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.
Special Physical/Mental Requirements None specified.
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.
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