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InsideHigherEd

Regulatory Assistant at InsideHigherEd

InsideHigherEd Chapel Hill, NC

Job Description

Department:LCCC - Clinical Trials-426806Career Area:Research ProfessionalsIs this an internal only recruitment?:NoPosting Open Date :12/10/2025Application Deadline:12/23/2025Position Type:Permanent Staff (SHRA)Position Title:Soc/Clin Research Assistant - JourneySalary Grade Equivalent:NC09 / GN08Working Title:Regulatory AssistantPosition Number:20040967Vacancy ID:P020694Full-time/Part-time Permanent/Time-Limited:Full-Time PermanentHours per week:40Work Schedule:Monday – Friday, 8:00AM – 5:00PMFlexible 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.Work Location:CHAPEL HILL, NCPosition Location:North Carolina, USHiring Range:$40,945 - $52,000Pay Band Information:To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.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:The primary purpose of this position is to provide para-professional support within the Office of Clinical Translational Research collaborating with the Regulatory staff of the Lineberger Clinical Protocol Office. The Regulatory Assistant gathers, edits, analyzes, and reports data/information for the purposes of communicating with the Institutional Review Board (IRB) and research sponsors. 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. The Regulatory Assistant participates in the collection, compilation, and management of data/information. The Regulatory Assistant is responsible for quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. The Regulatory Assistant is expected to use considerable sound judgment and their effective research skills in performing their work assignments. Work may include the training and supervision of staff, students and others.Minimum Education and Experience Requirements:Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.Required Qualifications, Competencies, and Experience: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.Preferred Qualifications, Competencies, and Experience:Knowledge of regulatory policy relating to clinical research and institutional review boards.Special Physical/Mental Requirements :Ability to lift/move 25 pounds with or without reasonable accommodations. Ability and willingness to push a cart with files between 4-5 buildings.Campus Security Authority Responsibilities:Not Applicable.Position/Schedule Requirements:Evening work occasionally, Overtime occasionally, Weekend work occasionally

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