Lead Study Coordinator

UNC-Chapel Hill • Chapel Hill, NC

5d

About The Position

The Lead Study Coordinator facilitates oncology clinical trials, including subject and data management, in accordance with federal regulations, Good Clinical Practice, and local and institutional policies. Reporting to the Clinical Operations Manager, the position independently manages multiple complex trials throughout protocol activation, implementation, and closure. The role also provides daily team leadership and programmatic support, leads patient care and advising activities, and serves as a preceptor for new hires by providing ongoing training and first-line support to staff. These responsibilities support the UNC / LCCC Protocol Office’s mission to maintain research quality, address patient safety and regulatory compliance, and safeguard institutional integrity.

Requirements

• Knowledge of ICH Good Clinical Practice, federal regulations, and guidelines, and ability to follow established regulations, procedures, and protocols.
• Advanced knowledge of clinical research coordination.
• Strong computer skills.
• Ability to contribute to preparing and delivering reports, trainings, and standard operating procedures (SOPs).
• Customer-oriented and team-oriented approach.
• Ability to communicate effectively and professionally, verbally and in writing.
• Ability to work evenings, weekends, and/or holidays occasionally.

Nice To Haves

• Previous clinical research experience involving tissue, questionnaires, and/or devices.
• Experience navigating medical records and extracting data.
• Experience sharing data and specimens among multiple institutions.
• Three years of clinical trial coordination experience, including two years in oncology.
• SOCRA or ACRP certification.

Responsibilities

• Independently manage multiple complex oncology clinical trials through activation, implementation, and closure.
• Manage trial subjects and data in accordance with applicable regulations, Good Clinical Practice, and local and institutional policies.
• Provide daily team leadership and programmatic support.
• Lead patient care and advising activities.
• Serve as a preceptor for new hires and provide ongoing training and first-line staff support.
• Contribute to the quality of research, patient safety, regulatory compliance, and institutional integrity.

What This Job Offers

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