Clinical Research Regulatory Coordinator

Monday-Friday- 8am-5pm.
Hybrid schedule- 3 days in office (Tue, Wed, Thurs) and 2 days work from home (Mon, Fri)

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

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.

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.

This position will serve as a Clinical Research Regulatory Coordinator within the UNC SOM Clinical Research Alliance ( CRA). The Clinical Research Participant Coordinator is responsible for research regulatory management for a variety of complex clinical research protocols, including leading efforts in gathering, editing, compiling, and reporting regulatory information. The Clinical Research Regulatory Coordinator will analyze and reconcile information from various sources to complete various regulatory based tasks, such as Institutional Review Board submissions and applications management, creation and maintenance of regulatory files, and quality assurance activities.

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

* Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

* Must be able to use considerable judgement and skills in performing work assignments. Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word.
* Demonstrated experience in clinical research, including knowledge of 21 CFR
* Demonstrate experience in study protocol assessment, IRB application preparation and submission, consent form preparation and submission
* Possess excellence in troubleshooting, including ability to analyze information, problems, situations, policies and procedures to define problem, needs or objectives and formulate alternatives for resolutions
* High level of accuracy and attention to detail
* Knowledge of medical terminology
* Experience preparing and submitting accurate and complete IRB submissions and consent forms.
* Demonstrated ability to provide consultation and lead discussions regarding regulatory actions and compliance.
* Solid writing skills and ability to prepare comprehensive reports
* Demonstrated ability to plan work to meet objectives and deadlines.
* Experience working with commercial/single institutional review boards (sIRBs) is required.

* Experience in preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, for therapeutic (interventional) clinical research studies involving a drug, device or combination.
* Experience using eRegulatory system (ex. Florence, Veeva Vault)
* SoCRa, or ACRP certification preferred
* Advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines.

Not Applicable.

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.

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.