What are the responsibilities and job description for the Regulatory Coordinator position at University of North Carolina at Chapel Hill?
Posting Information
Department
Gastroint Biology and Dis Ctr - 429001
Career Area
Research Professionals
Posting Open Date
03/28/2025
Application Deadline
04/10/2025
Position Type
Temporary Staff (SHRA)
Position Title
Regulatory Coordinator
Position Number
20069931
Vacancy ID
S024987
Full-time/Part-time
Part-Time Temporary
Hours per week
30
Work Schedule
Position Location
North Carolina, US
Hiring Range
$25.00 - $30.00/per hour
Proposed Start Date
Estimated Duration of Appointment
6 months not to exceed 11 months
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 that include numerous retail and restaurant discounts, savings on local child care centers and special rates for performing arts events.
Primary Purpose of Organizational Unit
The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing 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. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
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 will 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 will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
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 will 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 will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.
Position Summary
The Center for Esophageal Diseases & Swallowing (CEDAS) at Chapel Hill is seeking a detail-oriented and experienced Regulatory Coordinator to support the CGIBD’s research team in managing regulatory processes for clinical trials. This part-time remote position offers flexibility while playing a vital role in ensuring compliance and efficiency in regulatory submissions, e-regulatory management, and clinical trial oversight.
Key Responsibilities:
Key Responsibilities:
- Utilize UNC Clinical Trial Management Systems (CTMS) such as OnCore and other internal platforms to track and manage study details.
- Oversee and maintain e-regulatory systems (Veeva Site Vault) to ensure compliance with regulatory requirements.
- Prepare, submit, and track IRB submissions across WCG IRB, Advarra IRB, and UNC IRB, ensuring timely approvals and updates.
- Manage and distribute critical study updates (e.g., protocol amendments, Informed Consent Forms (ICF), Investigator’s Brochures (IB)).
- Serve as the regulatory liaison, coordinating with the research team, and sponsors to facilitate smooth study execution.
- Ensure adherence to federal regulations, institutional policies, and sponsor requirements related to clinical research.
- Maintain accurate and organized regulatory documentation for internal audits and external inspections.
Minimum Education and Experience Requirements
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience
Experience in clinical research regulatory processes, including IRB submissions and e-regulatory systems.
Preferred Qualifications, Competencies, and Experience
Familiarity with UNC CTMS (OnCore) and Veeva Site Vault, strong organizational skills with attention to detail and the ability to manage multiple studies, excellent written and verbal communication skills, and ability to work independently in a remote setting while maintaining collaboration with research teams.
Special Physical/Mental Requirements
Campus Security Authority Responsibilities
Not Applicable.
Salary : $25 - $30
