"Clinical Research Regulatory Coordinator"

Job Details

Department: SOM Clinical Research Alliance-425701

Career Area: Research Professionals

Is this an internal only recruitment?: No

Posting Open Date: 09/08/2025

Application Deadline: 09/22/2025

Position Type: Permanent Staff (SHRA)

Position Title: Soc/Clin Research Assistant - Advanced

Salary Grade Equivalent: NC10 / GN10

Working Title: Clinical Research Regulatory Coordinator

Position Number: 20067699

Vacancy ID: P020516

Full-time/Part-time Permanent/Time-Limited: Full-Time Permanent

Hours per week: 40

Work Schedule: Monday-Friday 8am-5pm. Hybrid schedule- 3 days in office (Tue, Wed, Thurs) and 2 days work from home (Mon, Fri)

Work Location: CHAPEL HILL, NC

Position Location: North Carolina, US

Hiring Range: $55,886 - $73,745

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 will serve as a Clinical Research Regulatory Coordinator within the UNC SOM Clinical Research Alliance (CRA). The Clinical Research Participant Coordinator is responsible for research regulatory management for a variety of complex clinical research protocols, including leading efforts in gathering, editing, compiling, and reporting regulatory information. The Clinical Research Regulatory Coordinator will analyze and reconcile information from various sources to complete various regulatory based tasks, such as Institutional Review Board submissions and applications management, creation and maintenance of regulatory files, and quality assurance activities.

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: Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. Must be able to use considerable judgement and skills in performing work assignments. Strong written and verbal communication skills. Must be able 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. Demonstrated experience in clinical research, including knowledge of 21 CFR. Demonstrate experience in study protocol assessment, IRB application preparation and submission, consent form preparation and submission. Possess excellence in troubleshooting, including ability to analyze information, problems, situations, policies and procedures to define problem, needs or objectives and formulate alternatives for resolutions. High level of accuracy and attention to detail. Knowledge of medical terminology. Experience preparing and submitting accurate and complete IRB submissions and consent forms. Demonstrated ability to provide consultation and lead discussions regarding regulatory actions and compliance. Solid writing skills and ability to prepare comprehensive reports. Demonstrated ability to plan work to meet objectives and deadlines. Experience working with commercial/single institutional review boards (sIRBs) is required.

Preferred Qualifications, Competencies, and Experience: Experience in preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, for therapeutic (interventional) clinical research studies involving a drug, device or combination. Experience using eRegulatory system (ex. Florence, Veeva Vault). SoCRa, or ACRP certification preferred. Advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines.

Position/Schedule Requirements: Evening work occasionally, Overtime occasionally, Weekend work occasionally