Senior Assistant Study Coordinator

UNC-Chapel Hill • Chapel Hill, NC

3d • Onsite

About The Position

The UNC LCCC Cellular Therapy Program is a leading academic center in the United States specializing in identifying new tumor targets and developing and infusing novel CAR-T immunotherapy. This position provides crucial clinical data management support for the program's complex, early-phase adult and pediatric cellular and gene therapy clinical trials. The role ensures that all clinical data management activities adhere to federal regulations, Good Clinical Practice, and local and institutional policies. Key responsibilities include clinical data abstraction and review, query resolution, and reconciliation to support the delivery of high-quality clinical data. The position is also responsible for data entry, quality control review, and identifying and documenting data problems within the Electronic Data Capture (EDC) system, serving as the primary contact for data entry operations for the program.

Requirements

• Experience in clinical data management.
• Knowledge of federal regulations and Good Clinical Practice (GCP).
• Familiarity with Electronic Data Capture (EDC) systems.
• Ability to perform data abstraction, review, and reconciliation.
• Skills in query resolution.
• Attention to detail for quality control.

Responsibilities

• Provide clinical data management support for early-phase adult and pediatric cellular and gene therapy clinical trials.
• Ensure clinical data management activities comply with federal regulations, Good Clinical Practice, and institutional policies.
• Perform clinical data abstraction and review.
• Resolve data queries and perform reconciliation.
• Conduct data entry activities.
• Perform quality control reviews of clinical data.
• Identify and document data problems during EDC tracking and maintenance.
• Serve as the primary contact for data entry activities for the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed