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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 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.
Job Code: CLINICAL RESEARCH COORDINATOR
Job Level: 52
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: benefits/
Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: ; phone: ).
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.