Nurse Director (Clinical Research

Nurse Director (Clinical Research)

The Nurse Director (Clinical Research) leads daily nursing operations within a cancer-focused clinical research environment to ensure safe, efficient, and high-quality participant care and research activities. This role oversees clinical research management, clinical trial care, staff supervision, and the development and competency of nursing staff. The Nurse Director ensures strict compliance with institutional, state, and federal regulations, supports the implementation of complex oncology research protocols, and maintains close communication with executive leadership regarding trends, challenges, and opportunities in clinical research and patient care.

Responsibilities

• Oversee clinical research management activities to ensure safe, competent, and high-quality care for participants enrolled in oncology research protocols.
• Ensure all clinical research activities comply with institutional, state, and federal regulations, including Good Clinical Practice (GCP) and applicable guidelines such as DHHS, FDA, OHRP, NIH, HIPAA, and IRB requirements.
• Lead and supervise the delivery of clinical activities administered during research protocols, including screening, informed consent, active treatment, and follow-up phases.
• Plan and implement strategies to meet regulatory requirements for the care of research cancer participants, ensuring participant safety and adherence to protocol-specific procedures.
• Facilitate the implementation of clinical research protocols across their entire duration, coordinating nursing care and resources to support timely and accurate execution.
• Develop, implement, and maintain policies and procedures for assigned areas to ensure compliance with institutional, regulatory, and clinical trial standards.
• Collaborate with investigators and multidisciplinary teams to create and refine policies and procedures that align with regulatory requirements and support research objectives.
• Oversee compliance with clinical trials by monitoring adherence to protocols, investigating protocol deviations, and developing and implementing corrective action plans.
• Provide leadership in quality assurance and performance improvement initiatives, using data and feedback to enhance participant care and research processes.
• Recruit, hire, supervise, and evaluate clinical research nursing staff to ensure productivity, competency, and adherence to established standards.
• Provide guidance, supervision, and direction to nursing research staff, using situational leadership to foster their independence, professional growth, and accountability.
• Offer constructive feedback, recognize staff accomplishments, and support ongoing professional development and training for nursing staff involved in clinical research.
• Oversee staff performance through regular assessments and annual evaluations, and manage processes related to hiring, promotions, transfers, and disciplinary actions.
• Ensure sufficient staffing levels to meet participant care needs, including stepping in to provide direct patient care when necessary.
• Organize workloads and vacation schedules, and manage the use of contract staff and overtime while maintaining budget adherence and participant safety.
• Proactively plan staffing to meet fluctuating participant care demands, balancing staff requests with unit needs to ensure safe, high-quality service delivery.
• Monitor and evaluate workflow and resource utilization to support efficient operations and optimal participant care within clinical research settings.
• Maintain up-to-date knowledge of relevant regulations, guidelines, and best practices by attending training programs, workshops, and seminars related to clinical research and oncology care.
• Communicate effectively with executive management, providing updates on trends, regulatory changes, operational issues, and opportunities for improvement in clinical research nursing.
• Support a culture of curiosity, integrity, collaboration, respect, caring, and perseverance in all aspects of clinical research nursing practice.

Essential Skills

• Registered Nurse license obtained through graduation from an accredited School of Nursing.
• Master's or Doctoral degree in nursing or a related field.
• Minimum of five (5) years of oncology nursing experience.
• Minimum of three (3) years of supervisory experience, preferably in an ambulatory care setting.
• Three (3) years of experience in research is preferred, particularly within oncology clinical trials.
• Minimum of three (3) years of relevant professional experience in reviewing and evaluating budgets, organizational structures, administrative practices, and computer applications in a large healthcare, education, or government environment.
• Experience in clinical research, including clinical trial operations and participant care across screening, consent, treatment, and follow-up.
• Demonstrated ability to pre-screen patients for clinical research protocols, particularly in oncology.
• Strong knowledge of regulatory guidelines and standards,…