Soc/Clin Research Specialist-CEDAS

Monday - Friday, 8:00 AM - 5:00 PM, other times as needed

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.

The Center for Gastrointestinal Biology and Disease ( CGIBD) is seeking an experienced, part time Clinical Research Coordinator ( CRC) to support ongoing gastrointestinal (GI) clinical trials.

The CRC will support multiple investigator initiated and sponsor led clinical trials and will work closely with Principal Investigators, study teams, sponsors, and regulatory bodies to ensure high quality, compliant study conduct.

Research Study Execution
* Collect study data per protocol using a variety of methods, including surveys, clinical observations, electronic medical record abstraction, and biospecimen collection.
* Perform clinical tests and study procedures in accordance with study protocols and required training.
* Accurately record study data and complete electronic or paper case report forms in compliance with Good Clinical Practice ( ICH GCP) and ALCOA C principles.
* Maintain high standards of data quality and documentation integrity throughout the study lifecycle.

Regulatory & Clinical Research Operations Support
* Create, maintain, and organize essential study documentation (e.g., delegation of authority logs, training records).
* Develop, submit, and maintain regulatory applications and study materials, including informed consent forms and recruitment materials.
* Identify, gather, and retain required regulatory documentation in accordance with sponsor, IRB, and institutional requirements.
* Prepare for, coordinate, and participate in monitoring visits; resolve queries and support implementation of corrective actions as needed.
* Track, document, and report protocol deviations and adverse events; participate in root cause analyses (RCAs) and corrective and preventive action ( CAPA) development.
* Maintain study supplies and coordinate biospecimen processing, tracking, and shipment when applicable.

Participant Management
* Screen and recruit research participants per protocol and institutional SOPs.
* Coordinate and support participant visits and follow up activities.
* Track study enrollment and participant accrual metrics.

Project & Study Start Up Support
* Contribute to study start up activities, including document development, system setup, and coordination with sponsors and internal teams.
* Participate in site initiation visits, study start up meetings, and close out visits.
* Assess study needs and implement strategies to optimize visit flow, recruitment, and participant retention.
* Assist with the development of study source documents, checklists, data collection tools, and internal workflows.
* Independently communicate with sponsors, regulatory authorities, and UNC offices regarding study related matters, escalating issues as appropriate.

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.

* Prior experience as a Clinical Research Coordinator supporting interventional clinical trials
* Prior clinical research experience at UNC Chapel Hill with familiarity navigating UNC policies, workflows, and cross departmental processes.
* Demonstrated knowledge of GCP or human subjects research regulations.
* Strong organizational skills with attention to detail
* Working knowledge of OnCore, EPIC, IDS (Investigational Drug Services), Veeva Site Vault, Other CTMS platforms, IRT systems, or Central IRBs (e.g., Advarra, WCG IRB)

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.