Job Description

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 Duke Cancer Institute's Phase I Clinical Research Program is seeking an experienced and highly organized Clinical Research Coordinator to support the conduct of complex oncology clinical trials and research studies, including studies involving Investigational Products (IP). In this role, you will partner closely with Principal Investigators, research teams, sponsors, and participants to ensure high-quality study execution while maintaining compliance with institutional, regulatory, and protocol requirements.

You will play an integral role in participant recruitment, enrollment, study coordination, data collection, regulatory management, and study operations while contributing to innovative cancer research that advances patient care and scientific discovery.

Minimum Requirements

• Associate's degree.
• Minimum of two years of relevant clinical research experience.
• Completion of the DOCR North Carolina State Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.
• Proficiency using Microsoft Office applications, web-based software, and electronic systems.

Preferred Qualifications

• Oncology research experience.
• Clinical trials coordination experience.
• Experience working with research participants and multidisciplinary study teams.
• Training, education, or experience in cancer research.

Other Requirements

• Basic Life Support (BLS) certification through the American Heart Association or a Duke-approved equivalent course is required.
• Must maintain Duke-required research certifications, training requirements, and study-specific credentials.
• Knowledge of Good Clinical Practice (GCP), institutional policies, regulatory requirements, and clinical research ethics.
• This position is onsite. The work is performed on-site at a designated Duke assignment location.

Be Bold.

In this role, you will:

• Coordinate all aspects of complex oncology clinical trials, including participant recruitment, screening, enrollment, scheduling, consent processes, study visits, and protocol implementation.
• Maintain regulatory compliance by managing regulatory binders, enrollment documentation, adverse event reporting, delegation logs, study training records, and other required study documentation.
• Serve as the primary liaison for assigned studies, collaborating with principal investigators, sponsors, study teams, monitors, and research participants to ensure effective study execution.
• Manage study operations and financial activities, including participant reimbursement processes, study milestones, budget support, monitoring activities, site initiation visits, and study closeout activities.
• Enter and manage clinical research data within Electronic Data Capture (EDC) systems while ensuring data quality, security, accuracy, and regulatory compliance.
• Identify operational challenges, recruitment barriers, retention concerns, and data issues, and work collaboratively with study teams to develop and implement solutions.
• Support the development of new studies and assist with research compliance activities, including Conflict of Interest (COI) documentation, Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs).
• Provide leadership and mentorship to colleagues, participate in committees and project teams, and contribute to the advancement of clinical research through continuing education, presentations, and publications.

Choose Duke.

At Duke Cancer Institute, you will join a nationally recognized leader in cancer research, patient care, and clinical innovation. The Phase I Clinical Research Program plays a critical role in advancing novel therapies and treatment options through early-phase oncology clinical trials that impact patients locally and globally.

As part of the Oncology Clinical Research Unit, you will collaborate with dedicated physicians, researchers, nurses, and research professionals who are committed to excellence, innovation, and improving outcomes for patients with cancer. Duke offers a collaborative environment where professional growth, scientific discovery, and meaningful work come together to make a difference every day.