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 (DCI) Phase 1 Clinical Research Program is seeking a Clinical Research Nurse Coordinator Sr. to provide leadership for a clinical team conducting multiple complex oncology clinical trials and research studies, including studies involving Investigational Products (IP). In this role, you will play a critical part in advancing innovative cancer treatments while ensuring the highest standards of patient care, research compliance, and study execution.

As a senior clinical research leader, you will partner closely with principal investigators, research staff, sponsors, and multidisciplinary teams to support participant recruitment, study operations, regulatory compliance, financial oversight, and staff development. This role is ideal for an experienced oncology nurse and clinical research professional who is passionate about improving patient outcomes through cutting-edge research and collaborative leadership.

Minimum Requirements

• Graduation from an accredited BSN, Associate Degree in Nursing, or Nursing Diploma program.
• Current or compact Registered Nurse (RN) license in the State of North Carolina.
• Basic Life Support (BLS) certification.
• Twelve months of appropriate clinical nursing experience.
• Four years of clinical research experience.
• Ability to maintain compliance with required hospital, unit, and regulatory training requirements.
• Knowledge of Good Clinical Practice (GCP), research regulations, and clinical trial operations.

Preferred Qualifications

• Two years of oncology nursing experience.
• Two years of clinical research experience in oncology trials.
• Leadership, supervisory, or management experience.
• Experience supporting complex clinical trials, including Phase I oncology studies.
• Experience with study budgets, financial management, and clinical trial closeout activities.
• Strong communication, mentoring, and problem-solving skills.

Other Requirements

• Maintain active RN status with the North Carolina Board of Nursing.
• Maintain required hospital, department, and protocol-specific certifications and training.
• Ability to work within the professional scope of nursing practice as it relates to clinical research.
• Ability to oversee and train research staff and nursing personnel.

Be Bold.

Lead Complex Oncology Clinical Trial Operations

• Direct and oversee day-to-day execution of multiple complex oncology clinical trials and research studies.
• Coordinate study startup, initiation, enrollment, monitoring, and closeout activities.
• Partner with principal investigators and study teams to support participant recruitment, enrollment, informed consent, and retention efforts.
• Identify operational challenges and implement solutions to enhance study performance and participant experiences.

Ensure Research Compliance and Regulatory Excellence

• Oversee compliance with institutional policies, federal regulations, sponsor requirements, and protocol-specific procedures.
• Ensure timely documentation and reporting of adverse events, regulatory submissions, enrollment activities, and study records.
• Maintain oversight of regulatory binders, delegation logs, study training documentation, and participant registration systems.
• Lead development of Conflict of Interest (COI), Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs).
• Coordinate external monitoring activities and ensure audit readiness.

Manage Research Finances and Study Resources

• Monitor study financial milestones, participant reimbursement processes, and research-related expenses.
• Collaborate with financial teams on budget planning, study forecasting, invoicing, and contract management activities.
• Lead study budget oversight and financial closeout processes.
• Ensure appropriate stewardship of research resources and funding.

Develop and Mentor High-Performing Teams

• Supervise, mentor, and support clinical research staff while fostering a culture of collaboration, accountability, and professional growth.
• Establish measurable performance goals and provide ongoing coaching and feedback.
• Coordinate staff assignments, cross-training initiatives, and workforce planning activities.
• Oversee training, certifications, and competency requirements to ensure compliance with clinical research standards and SOPs.
• Serve as a subject matter expert and trusted resource for colleagues and research teams.

Promote Data Integrity, Ethics, and Quality

• Ensure research data are collected, managed, and maintained according to established quality and security standards.
• Review study documentation and data for completeness, accuracy, and regulatory compliance.
• Identify data quality concerns and implement corrective actions.
• Educate study teams on ethical principles, professional standards, and regulations governing clinical research.
• Uphold Duke's commitment to excellence in patient care, research integrity, and innovation.

Choose Duke.

At the Duke Cancer Institute, you'll join one of the nation's leading academic cancer centers, where groundbreaking research and exceptional patient care come together to transform lives. The Phase 1 Clinical Research Program provides patients access to innovative therapies and first-in-human clinical trials that help shape the future of cancer treatment.

As part of Duke, you'll work alongside nationally recognized physicians, researchers, nurses, and clinical research professionals dedicated to advancing discoveries from the laboratory to the bedside. We foster a culture built on excellence, collaboration, innovation, and compassion while supporting the professional growth and development of our team members.

Job Code: 00001204 CLINICAL RESEARCH NURSE COORDINATOR, SR

Job Level: 55

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $78,347.00to USD $133,188.00. 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: https://hr.duke.edu/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: DAAS@duke.edu; phone: 919-668-1267).