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.

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/