Social/Clinical Research Specialist - Jackson

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 is to serve as the Senior Clinical Research Coordinator in the Center for Gastrointestinal Biology and Disease ( CGIBD). The Senior Clinical Research Coordinator is responsible for the planning, organization, conduct, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies and solutions to improve study processes and execution, providing reviews of other team members' work product, and serving as mentor and subject matter expert. This includes independently coordinating the most complex investigational drug and device trials within their assigned unit. The Senior Clinical Research Coordinator will lead the study start up activities when new industry-sponsored trials are launched. This includes interpreting protocol requirements to determine how all aspects of the trial will be implemented at UNC. Collaborating with institutional partners (investigators, IRBs, CTRC, and IDS) to complete all tasks required for site activation (writing and submitting IRB applications, writing and submitting nursing orders at the CTRC, collaborating with IDS staff for Epic build, and partnering with BCA team to create billing calendars); collaborating with external partners (study sponsors and CROs) to complete site visits, provide documentation about UNC's policies, complete sponsor's regulatory requirements and training requirements for investigators and staff. Responsible for solving complex issues/barriers prior to site activation when the sponsor and institution do not align.

Employing extensive clinical research regulatory knowledge, including mastery and understanding of good clinical practice ( ICH/ GCP), FDA code of federal regulations, and UNC regulations/ policies related to human subjects research, the Senior Clinical Research Coordinator will be responsible for advanced complex trial coordination of multiple trials (for example, infusion drug studies with chronically ill patients), independently managing advanced regulatory tasks (including IRB submissions to local and central IRBs, daily communications with industry and federal sponsors, preparing for audits, etc.), and providing leadership to the team of research coordinators. The Senior Clinical Research Coordinator may also manage small scale multi-site projects from the ground-up including the overall management of investigational clinical trial research protocols at UNC and participating sites, detailing the operation of study procedures, hypothesis, and aims, case report form design, database design, multi-site data and regulatory management, as well as assist research managers with staff training and quality assurance.

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.

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.