Oncology Clinical Trials Nurse

Job Title: Clinical Research Nurse Coordinator (Pediatrics)

This role serves as a Research Nurse Clinician within a comprehensive oncology clinical trials program, with a focus on pediatric studies. The Clinical Research Nurse Coordinator ensures safe, effective, and patient-centered conduct of clinical trials by supporting protocol activation, screening and enrolling participants, and providing protocol-driven clinical management throughout the study. The position bridges direct patient care and research operations, working closely with investigators, multidisciplinary clinical teams, and research administration to maintain regulatory compliance, data integrity, and high-quality oncology nursing care.

Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols using established study start-up task lists.

Verify Scientific Review Board, Institutional Review Board, data collection plans, and finance/contract approvals prior to study activation.

Review protocols and gather multidisciplinary logistical, educational, and financial feedback to identify and resolve obstacles to safe and effective study conduct in collaboration with the Principal Investigator.

Provide one-on-one and group protocol-related nursing education to other disciplines to support safe and effective care of enrolled patients.

Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders.

Work with the clinical research team to ensure timely prescreening of potential subjects and active cancer patients for available clinical trials.

Review patient charts and medical histories to confirm protocol eligibility and obtain necessary source documents.

Conduct the informed consent process in accordance with IRB, GCP, and institutional policies, ensuring consent is properly obtained, documented, and filed in the medical record.

Provide back-up support to register consented research patients with study sponsors and enter data into the OnCore clinical trials database.

Complete precertification forms and provide anticipated clinical information to financial counselors, responding to payer queries and serving as a resource for clinical trial billing information based on the billing grid.

Serve as a key liaison between patients and members of the research team, ensuring clear communication and coordination of care.

Ensure protocol-specific orders are entered and executed accurately, including scheduling and completion of tests and appointments within and outside the health system, from eligibility work-up through end-of-study transition.

Coordinate and oversee continuity of protocol-specified procedures and treatments across disciplines and sites of care, including inpatient needs related to the study protocol.

Coordinate patient reimbursement while on clinical trials, including management of institutional or study-specific reimbursement cards.

Deliver high-quality, compassionate, hands-on oncology nursing care in accordance with protocol requirements and GCP guidelines, collaborating with clinical teams, investigators, and ancillary departments such as pathology, radiology, laboratory, surgery, and infusion services.

Conduct nursing assessments of study patients by phone or in person and route patients appropriately for additional or urgent care needs.

Document nursing assessments and protocol-specific visits accurately using institutional templates, reconcile concomitant medications, and ensure clear communication regarding patients who are off treatment or off study.

Collaborate with integrated academic medical system staff to coordinate timely services for patients and promote teamwork by delegating tasks appropriately.

In collaboration with physicians, accurately grade adverse events using NCI common toxicity criteria or protocol-specific grading scales and provide informal teaching on toxicity assessment and grading.

Complete Serious/Unexpected Adverse Event forms and follow-up reports in accordance with sponsor, federal, and institutional requirements, ensuring physician attribution is included.

Monitor overall protocol compliance with the assigned team and assist with deviation reporting per IRB guidelines, institutional policies, and protocol requirements.

Provide back-up support to collaborate with clinical trial laboratories to ensure proper collection, processing, and submission of study-specific biospecimens and related documentation.

Assist with monitoring visits and audits, providing accurate and timely responses to sponsor queries and participating in conference calls as needed.

Support the clinical study team in completing Case Report Forms and resolving database queries.

Maintain complete and accurate research records for screened and enrolled patients, including consents, eligibility documentation, case report forms, registration confirmations, and source documents.

Model a high level of professional responsibility and performance in all aspects of research nursing practice.

Pursue professional growth through continuing education and skill building, maintaining state and certifying body-mandated continuing education requirements and setting annual professional development goals.

Use computerized systems such as clinical and disease management platforms, medical records databases, and other institutional systems to complete core tasks including SAE documentation, protocol access, and study calendar preparation.

Attend training programs, modules, workshops, and seminars offered by research support services, and actively participate in disease-specific meetings, quality assurance activities, and process improvement initiatives.

Provide training, orientation, and preceptorship to other faculty and staff as needed, supporting the development of colleagues in clinical research.

Ensure adherence to all applicable institutional, state, and federal regulations throughout the life cycle of research projects and protocols, including IRB approvals and compliance with approved protocols.

Maintain up-to-date knowledge of and adherence to institutional policies, procedures, guidance, and practice standards, and complete all mandatory institutional requirements and education.

Comply with corporate compliance policies, codes of conduct, and conflict of interest policies, and demonstrate alignment with institutional core values.

Adhere to all relevant federal, state, and institutional regulations, laws, and policies as they evolve, maintaining annual completion of mandatory educational activities.

Graduate of an accredited school of nursing with a current license to practice as a registered nurse in the State of New Jersey.

One (1) year of oncology experience required, with demonstrated competence in oncology patient care.

Clinical research coordinator experience of 2–3 years, including experience with screening, recruitment, enrollment, and management of study subjects.

Oncology experience specifically in clinical research settings, with the ability to support oncology-focused trials.

Experience and comfort communicating directly with patients and families in clinical and research contexts.

Demonstrated ability to conduct and document informed consent processes in alignment with IRB, GCP, and institutional policies.

Proficiency in reviewing medical records, confirming protocol eligibility, and managing source documentation.

Ability to coordinate complex clinical trial workflows, including scheduling, protocol-specific procedures, and multidisciplinary communication.

Proficiency in computer applications and electronic systems, including clinical research platforms, word processing, and spreadsheets.

Understanding of FDA, IRB, and Good Clinical Practice (GCP) regulations related to clinical research.

Ability to grade and document adverse events using NCI common toxicity criteria or protocol-specific scales.

Strong communication and interpersonal skills, with the ability to collaborate effectively with investigators, clinical teams, and research staff.

Ability to adhere to institutional policies, regulatory requirements, and corporate compliance standards.

Bachelor’s Degree in Nursing (BSN) preferred.

Three (3) to five (5) years of oncology research experience preferred.

Oncology Nursing Society certification as an Oncology Certified Nurse (OCN) or Advanced Oncology Certified Nurse (AOCN) preferred.

Association of Clinical Research Professionals certification (such as CRA) or Society of Clinical Research Associates certification as a Clinical Research Professional (CCRP) preferred.

Interest in attaining and maintaining oncology-specific certifications such as OCN.

Experience working with clinical trial management systems such as OnCore or similar platforms.

Familiarity with institutional systems for clinical and disease management, medical records, and research documentation.

Comfort working within multidisciplinary disease-specific groups, including adult and pediatric oncology teams.

Ability to participate in and contribute to quality assurance activities, audits, and process improvement initiatives.

Experience providing education, orientation, or preceptorship to other nurses or research staff.

Capacity to adapt to evolving regulations, institutional policies, and research priorities.

This is a Contract to Hire position based out of New Brunswick, NJ.

If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

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