Regulatory Assistant

Regulatory Assistant Posting Information Posting Information Department LCCC

• Clinical Trials-426806 Career Area Research Professionals Is this an internal only recruitment? No Posting Open Date 05/14/2026 Application Deadline 05/20/2026 Position Type Permanent Staff (SHRA) Position Title Soc/Clin Research Assistant
• Journey Salary Grade Equivalent

NC09 / GN08

Working Title Regulatory Assistant Position Number 00060071 Vacancy ID P021022 Full-time/Part-time Permanent/Time-Limited Full-Time Permanent If time-limited, estimated duration of appointment Hours per week 40 Work Schedule Monday

• Friday, 8:00AM
• 5:00PM Work Location

CHAPEL HILL, NC

Position Location North Carolina, US Hiring Range $40,945

• $52,000 Pay Band Information To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

Position Summary Information 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 The UNC Lineberger Comprehensive Cancer Center (LCCC), founded in 1975, is a designated National Cancer Institute (NCl

• designated comprehensive cancer center.

The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach. UNC LCCC's Clinical Trials Office (CTO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The CTO provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The CTO is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large. Position Summary The purpose of this position is to facilitate the conduct of oncology clinical trials by providing regulatory document support to ensure compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for: Regulatory Essential Document Collection and Regulatory Binder Maintenance

• Preparing, collecting, and obtaining signatures for essential documents for electronic regulatory binder, including delegation of authority/delegation of task log, financial disclosure forms, Form FDA 1572, training documentation, protocol signature page, IB acknowledgments, lab certifications, medical licenses, CVs
• Maintaining regulatory binder, including naming regulatory documents in accordance with defined nomenclature, filing regulatory documents in eRegulatory binder in accordance with defined filing structure
• Communicating with sponsors and monitors regarding status of essential regulatory documents and providing essential documents as required
• Tracking and recording pending regulatory actions through completion on study team trackers
• Providing updates on status of pending regulatory actions at study team meetings (oral and/or written) and takes meeting minutes
• Accurately entering IRB approval information into the electronic clinical research management system (OnCore) and uploading study documents into OnCore within required deadlines
• Other duties as assigned Monitoring and Auditing Compliance
• Preparing regulatory binder for monitoring and audit visits and addresses regulatory findings within required deadlines.

Portfolio Management:

Regulatory IRB Applications

• Preparing, submitting, and processing in a timely and accurate manner IRB applications for: o continuing reviews for closed to accrual studies with all patients off treatment to the IRB of record o personnel modifications to UNC IRB o external IND safety reports to UNC IRB This position may include involvement in process improvements:
• Developing, writing and providing input on standard operating procedures, work instructions, and internal processes.
• Mentoring new Regulatory team members
• Participating on CTO committees/task forces/working groups
• Assisting in training Regulatory team members as needed
• Attending pre-study team regulatory meetings for assigned study teams These responsibilities relate to the

UNC/LCCC

Clinical Research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity. Minimum Education and Experience Requirements Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. Management Preferences

• Working knowledge and facility with information technology, including Microsoft Outlook, Word, Excel, and PowerPoint.
• Ability to organize, record, and present information in addition to communicate professionally both verbally and in writing.
• 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.
• Knowledge of regulatory policy relating to clinical research and institutional review boards.

Required Licenses/Certifications Special Physical/Mental Requirements Position requires sitting for extended periods of time. Campus Security Authority Responsibilities Not Applicable. Position/Schedule Requirements Evening work occasionally, Overtime occasionally, Weekend work occasionally Special Instructions (Open Ended Question)