Clinical Research Coordinator, Senior - Duke Cancer Institute

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

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).

You will partner closely with Principal Investigators (PIs) and multidisciplinary teams to recruit, enroll, and support study participants while ensuring studies are conducted efficiently, ethically, and in compliance with institutional and regulatory requirements. This is an opportunity to take ownership of complex oncology trials, contribute to innovative research, and directly impact patient care and scientific advancement.

Minimum Requirements:

• Associate's degree
• Minimum of six years of research experience
• A Bachelor's degree may substitute for two years of required experience

Preferred Qualifications:

• Oncology, hematology, or cellular therapy research experience
• Clinical trials coordination experience
• Experience in complex, multi-protocol research environments
• Management experience

Other Requirements:

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

Work Location:

• Onsite. The work is performed on-site within the Oncology Clinical Research Unit.

Be Bold.

Position 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
• Perform other related duties as assigned

Choose Duke.

Join the Duke Cancer Institute's Oncology Clinical Research Unit and be part of a nationally recognized leader in cancer care, research, and innovation. Within the Hematologic Malignancies and Cellular Therapy program, you will contribute to cutting-edge clinical trials that advance treatments for leukemia and other serious conditions.

At Duke, you'll work in a highly collaborative environment that values excellence, discovery, and "Cancer Care as It Should Be." You'll have the opportunity to lead meaningful research initiatives, mentor emerging professionals, and directly impact patient outcomes.