Regulatory Assistant

Monday - Friday, 8:00AM - 5:00PM

Flexible work arrangements, including remote/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as virtual. Please note that the designated work location is subject to change based on the unit's business needs.

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.

The primary purpose of this position is to provide regulatory document support within the Regulatory staff the Lineberger Clinical Protocol Office. The Regulatory Assistant prepares and ensures the completion of essential documents by clinical research personnel, accurately maintains the regulatory binder for clinical research studies, and communicates regularly with study sponsors, investigators, and LCCC staff regarding the status and completion of essential regulatory documents. This work is performed in order to comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research. Regulatory Assistants participate in the collection, compilation, and management of data/information; quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. Regulatory Assistants are expected to use considerable judgment and research skills in performing their work assignments. Work may include the training of staff and others.

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

Working knowledge and facility with information technology, including Microsoft Outlook, Word, Excel, and PowerPoint; ability to organize, record, and present information; ability to lead exchange of information through dialog, instruction, and demonstration; ability to develop working knowledge of regulatory requirements and procedures relating to essential document collection for oncology clinical research; ability to communicate professionally both verbally and in writing.

Knowledge of regulatory policy relating to clinical research and institutional review boards.

Position requires sitting for extended periods of time. Ability to move 25 pounds with or without reasonable accommodations. Ability and willingness to push a cart with files between 4-5 buildings.

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.