Soc/Clin Research Specialist

40 hours per week, Monday - Friday.

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.

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 entail independently managing regulatory activities for numerous industry sponsored clinical trials and other research projects at the Thurston Arthritis Research Center. Key aspects of the position will include communication and coordination with industry sponsors, research organizations and UNC offices/units as necessary. The position will be responsible for managing regulatory submissions throughout the study lifecycle including but not limited to IRB submissions, reviewing and routing contracts and amendments, and all managing regulatory documentation. The coordinator will also track regulatory deadlines and reporting requirements as well as prepare documentation for monitoring visits and audits. The coordinator will coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with appropriate regulations, Standard Operating Procedures, and study specific protocols. The Clinical Trials Study Coordinator will also participate in other clinical research activities as necessary at the Thurston Arthritis Research Center.

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.

Demonstrated ability to coordinate regulatory activities for therapeutic clinical trials, including study start-up, amendments, continuing reviews, reportable events, or study closeout.

Strong understanding of FDA, ICH- GCP, sponsor, or institutional regulatory requirements governing clinical research.

Exceptional attention to detail with a commitment to maintaining accurate, complete, or audit-ready regulatory documentation.

Ability to effectively manage multiple studies while ensuring compliance with regulatory or sponsor requirements.

Ability to collaborate effectively with investigators, study teams, sponsors, or regulatory oversight committees.

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.