Clinical Research Coordinator - 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 Duke Cancer Institute's Adult Bone Marrow Transplant, Hematologic Malignancies & Cellular Therapy Clinical Research Program is seeking a Clinical Research Coordinator to join our Multiple Myeloma Clinical Research Team. In this role, you will lead and coordinate complex Phase I-III clinical trials that advance groundbreaking therapies for patients with multiple myeloma and other hematologic malignancies.

You will serve as a key member of a multidisciplinary research team responsible for managing all aspects of clinical trial operations, participant coordination, regulatory compliance, investigational product management, data integrity, and sponsor collaboration. This position offers an exciting opportunity to contribute directly to innovative cancer research while working alongside nationally recognized physicians, scientists, and clinical research professionals.

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 with Microsoft Office applications and web-based software systems
• Experience maintaining accurate records, documentation, and regulatory files
• Strong organizational, communication, and time management skills

Preferred Qualifications

• Oncology clinical research experience
• Clinical trials coordination experience
• Experience supporting Phase I, II, or III clinical trials
• Experience working with investigational products and protocol-driven research
• Knowledge of FDA regulations, Good Clinical Practice (GCP), IRB requirements, and human subject protections
• Experience using clinical research systems such as OnCore, eREG, iRIS, or electronic health records
• Experience supporting hematology, oncology, bone marrow transplant, or cellular therapy research programs

Other Requirements

• Basic Life Support (BLS) certification from the American Heart Association or Duke-approved equivalent is required
• Ability to support participant visits, specimen collection activities, monitoring visits, and study-related meetings
• Must maintain compliance with institutional, sponsor, FDA, and study-specific requirements
• May provide training, guidance, and oversight to other research staff

Be Bold.

As a Clinical Research Coordinator, you will:

• Lead and coordinate complex oncology clinical trials by managing study startup, participant enrollment, protocol implementation, monitoring visits, study closeout activities, and compliance with institutional, sponsor, and regulatory requirements.
• Manage participant recruitment, screening, consent, retention, and study visit activities for interventional and procedural studies, ensuring participant safety, protocol adherence, and accurate documentation throughout the research lifecycle.
• Serve as the primary liaison between sponsors, investigators, research teams, regulatory offices, and clinical partners while supporting feasibility assessments, regulatory submissions, investigational product management, monitoring visits, and audit readiness activities.
• Oversee research data collection, quality assurance, reporting, and documentation by maintaining accurate clinical databases, supporting data analysis efforts, preparing study reports, and ensuring compliance with FAIR data principles and data-sharing requirements.
• Support scientific and regulatory activities through adverse event reporting, IRB submissions, FDA documentation, protocol development support, literature reviews, publication activities, and continuous process improvement initiatives.

Key Responsibilities:

Clinical Trial Operations & Study Management

• Coordinate multiple Phase I-III oncology clinical trials and research studies
• Develop and maintain study-specific operational workflows and documentation
• Support protocol activation, implementation, ongoing management, and closeout
• Facilitate study feasibility assessments and operational planning
• Manage international study documentation when applicable
• Prepare studies for monitoring visits, audits, inspections, and closeout activities
• Ensure research supplies and equipment are available and operational
• Utilize OnCore, eREG, and other research systems to manage research protocols and participant activities

Regulatory & Compliance Management

• Prepare, submit, and maintain regulatory documentation
• Collaborate with ORAQ on FDA submissions and regulatory reporting requirements
• Support sponsor, IRB, FDA, and institutional compliance activities
• Prepare and submit IRB applications, amendments, continuing reviews, and reportable events through iRIS
• Ensure compliance with federal regulations, institutional policies, GCP guidelines, and sponsor requirements

Participant Management

• Screen participants for eligibility and enrollment
• Conduct and document informed consent processes
• Coordinate study visits and protocol-required procedures
• Implement recruitment and retention strategies
• Monitor participant safety and protocol compliance
• Identify, document, and report adverse events and safety concerns

Investigational Product Management

• Manage all aspects of investigational product accountability
• Coordinate receipt, storage, tracking, dispensing, and documentation of study drug inventory
• Serve as liaison with sponsors, Investigational Drug Services (IDS), and clinical teams
• Support randomization and blinding/unblinding processes in accordance with study protocols

Data Management & Reporting

• Collect, enter, verify, and maintain research data
• Ensure data accuracy, completeness, and quality across assigned studies
• Develop data collection tools and quality assurance processes
• Support data management plans and sponsor reporting requirements
• Generate reports, data summaries, tables, and visualizations for investigators and stakeholders
• Assist with repository submissions and research data sharing activities

Leadership & Professional Development

• Participate in departmental committees, workgroups, and continuous improvement initiatives
• Provide guidance and training to research staff as appropriate
• Assist in developing SOPs, tools, and resources for research operations
• Maintain current knowledge of clinical research regulations, industry trends, and therapeutic developments
• Actively contribute to a culture of collaboration, innovation, and excellence

Scientific Contributions

• Conduct literature searches and reviews
• Support protocol development and study design activities
• Assist with grant and funding proposal development
• Contribute to abstracts, posters, presentations, and publications
• Collaborate with investigators on scientific and operational initiatives

Choose Duke.

At Duke Cancer Institute, you will join one of the nation's leading academic cancer centers dedicated to advancing innovative treatments and improving outcomes for patients with cancer. The Multiple Myeloma Clinical Research Team conducts cutting-edge clinical trials that help bring new therapies and treatment approaches to patients facing complex hematologic diseases.

Duke offers a collaborative and mission-driven environment where research professionals partner with world-renowned physicians, scientists, and healthcare teams to transform discoveries into life-changing patient care. Your work will directly support clinical innovation, scientific advancement, and improved patient outcomes.