Clinical Research Coordinator, Senior - Duke Cancer Institute

About the role

The Oncology Clinical Research Unit (CRU) within the Duke Cancer Institute is seeking a Clinical Research Coordinator Sr. to support the Leukemia/MPN Clinical Research Team (CRT) within the Hematologic Malignancies & Cellular Therapy (HMCT) Clinical Research Program. In this role, you will supervise a team of study coordinators and data managers/coordinators as part of your leadership of the day-to-day operations of a clinical research team conducting multiple, complex oncology clinical trials, including studies involving Investigational Products (IP).

Responsibilities

• Lead study operations and coordination for multiple complex oncology clinical trials, including participant recruitment, screening, enrollment, and retention strategies; evaluate processes and implement solutions to improve study performance
• Oversee study and site management activities, including regulatory compliance, maintenance of study documentation (regulatory binders, enrollment logs, Delegation of Authority logs), adverse event reporting, and participant registration in systems of record
• Collaborate with Principal Investigators and study teams to implement new studies, develop key documents such as Conflict of Interest (COI), Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs), and troubleshoot study-related challenges
• Manage financial and operational aspects of trials, including tracking study milestones, documenting study payments and participant care expenses, supporting budget development, and assisting with study closeout activities
• Serve as the primary liaison between sponsors, PIs, and study personnel; communicate effectively and professionally while ensuring timely responses to inquiries and study needs
• Support data integrity and management, including use of Electronic Data Capture (EDC) systems, resolving sponsor queries, identifying data issues, and ensuring completeness, accuracy, and security of research data
• Lead and supervise research staff, including assigning work, managing performance, supporting professional development, conducting training, and ensuring compliance with protocols, SOPs, and regulatory requirements
• Foster a collaborative and high-performing team culture by promoting open communication, mentoring staff, setting measurable goals, and encouraging innovation and accountability
• Ensure ethical conduct of clinical research, educating staff and participants on the distinction between clinical care and research, and reinforcing adherence to professional guidelines, regulatory standards, and institutional policies

Requirements

• Associate’s degree
• Minimum of six years of research experience
• A Bachelor’s degree may substitute for two years of required experience
• Oncology, hematology, or cellular therapy research experience preferred
• Experience in clinical trials coordination preferred
• Experience in complex, multi-protocol research environments preferred
• Management experience preferred

Other Requirements

• Basic Life Support (BLS) certification from the American Heart Association or a Duke-approved equivalent is required
• Maintain required certifications, training, and compliance with SOPs, regulations, and protocol requirements