Clinical Research Specialist

Department: Gastroint Biology and Dis Ctr-429001 Career Area : Research Professionals Posting Open Date: 08/25/2026 Application Deadline: 09/08/2026 Open Until Filled: No Position Type: Permanent Staff (EHRA NF) Working Title: Social/Clinical Research Specialist - Jackson Appointment Type: EHRA Non-Faculty Position Number: 20041269 Vacancy ID: NF0009972 Full Time/Part Time: Full-Time Permanent FTE: 1 Hours per week: 40 Position Location: North Carolina, US Hiring Range: Dependent on Experience and Qualifications Proposed Start Date: 10/05/2026 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 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. Primary Purpose of Organizational Unit: 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. Position Summary: 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. 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: Strong written and verbal communication skills. Ability 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. Ability to interact with clinical investigators, laboratory personnel, study sponsors, IRB, Office of Clinical Trials, and support staff. Working knowledge of medical terminology, techniques, and methodologies used in developing, coordinating, and managing clinical research projects. Working knowledge of FDA Code of Federal Regulations (CFR) and International Conference on Harmonisation Good Clinical Practice (ICH GCP) as well as familiarity with local, state, and federal guidelines governing clinical trials. Experience in initiating, maintaining, and updating protocols with central and local IRBs and minting the appropriate regulatory documents. Working knowledge of database management and spreadsheets. Ability to learn quickly, work independently and efficiently with minimal supervision, prioritize tasks, and work under deadline pressure. Flexibility is required for intermittent evening and weekend hours as needed for patient enrollment after normal business hours. Preferred Qualifications, Competencies, and Experience: Experience with clinical research (including the UNC IRB processes, FDA regulatory requirements, ICH GCP guidelines, ACRP or SOCRA certification) is strongly desired. Gastrointestinal clinical trial experience and familiarity with both NIH and industry-sponsored research studies preferred. Management and leadership experience is highly desired. Campus Security Authority Responsibilities: Not Applicable. #J-18808-Ljbffr