Clinical Research Nurse Coordinator

Clinical Research Nurse

This role focuses on the safe, effective, and patient-centered conduct of oncology clinical trials within an academic, NCI-designated cancer center. The Clinical Research Nurse collaborates closely with investigators and the broader research team to activate new protocols, screen and enroll participants, and provide ongoing protocol-driven clinical management. The position serves as a key link between patients and multidisciplinary teams, ensuring adherence to regulatory requirements, Good Clinical Practice (GCP), and institutional policies while supporting high-quality oncology care and research.

Responsibilities

• Collaborate with the protocol activation office to initiate and activate new clinical trial protocols using established study start-up task lists.
• Prepare and review study tools such as study binders, medication diaries, eligibility checklists, and flow sheets as required.
• Verify approvals from Scientific Review Boards, Institutional Review Boards, data collection plans, and finance/contract offices prior to study activation.
• Review protocols and collect logistical, educational, and financial feedback from multidisciplinary stakeholders to identify potential obstacles to safe and effective study conduct.
• Proactively identify and resolve study-related obstacles in collaboration with the Principal Investigator.
• Provide one-on-one and group protocol-related nursing education to other disciplines to promote safe and effective care of enrolled patients.
• Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders.
• Collaborate with the clinical research team to ensure timely prescreening of potential subjects and active oncology patients for available clinical trials.
• Review patient charts and medical histories to confirm protocol eligibility and obtain required source documents.
• Conduct the informed consent process in accordance with IRB, GCP, and institutional policies, ensuring proper documentation and provision of copies to patients.
• Obtain informed consent for both therapeutic and non-therapeutic studies as assigned.
• Provide back-up support to register consented research participants with study sponsors and enter data into the OnCore clinical trials database.
• Complete precertification forms, provide anticipated clinical information to financial counselors, and respond to payer queries regarding clinical trial billing information.
• Serve as an essential link between patients and all members of the research team, ensuring clear communication and coordination of care.
• Identify and communicate challenges related to protocol-required procedures and timelines to the study team and supervisor, and participate in problem resolution.
• Ensure accurate entry and execution of protocol-specific orders, including scheduling and completion of required tests and appointments across internal and external sites.
• Coordinate and oversee continuity of protocol-specified procedures and treatments between disciplines and sites of care, including inpatient settings.
• Coordinate patient reimbursement while on clinical trials, including the use of institutional or study-specific payment cards.
• Provide high-quality, compassionate, hands-on oncology nursing care in coordination with clinical teams, investigators, and ancillary departments such as pathology, radiology, clinical laboratory, surgery, and infusion services.
• Conduct nursing assessments of study patients in person or by phone and direct patients appropriately for additional or urgent care needs.
• Document nursing care and protocol visits accurately and completely using institutional templates, ensuring reconciliation of concomitant medications and clear communication regarding patient status on or off treatment and study.
• Drive collaboration with integrated academic medical system staff to ensure timely delivery of services to patients and promote effective teamwork.
• In collaboration with physicians, accurately grade adverse events using National Cancer Institute common toxicity criteria or protocol-specific grading scales and provide informal teaching on toxicity assessment.
• Complete Serious/Unexpected Adverse Event forms and follow-up reports as required by sponsors, regulatory requirements, and institutional guidelines, ensuring appropriate physician attribution.
• Assess overall protocol compliance with the assigned team and assist with deviation reporting in line with IRB guidelines, institutional policies, and protocol requirements.
• Provide back-up support to coordinate with the Clinical Trial Lab to ensure proper collection, processing, and submission of study-specific biospecimens and related case report forms.
• 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 organized research records, including consents, eligibility documents, case report forms, registration confirmations, and source documents for screened and enrolled patients.
• Model a high level of professional responsibility and performance in all aspects of clinical research nursing.
• Pursue professional growth through continuing education and skill-building, maintaining required continuing education and setting annual professional goals.
• Use computerized systems such as clinical management platforms, electronic medical records, and research databases to complete core tasks, including SAE documentation, accessing protocol attachments, and generating patient study calendars.
• Attend training programs, workshops, seminars, and disease-specific group meetings to stay current with departmental objectives and quality initiatives.
• Participate in audits, meetings with Principal Investigators, task forces, committees, and process improvement initiatives as assigned.
• Provide training, orientation, and preceptorship to faculty and staff involved in clinical research as needed.
• Ensure adherence to institutional, state, and federal regulations throughout the lifecycle of research projects and protocols.
• Confirm that all research protocols receive Institutional Review Board approval and are conducted according to the approved documents.
• Maintain up-to-date knowledge of and adherence to policies, procedures, guidance, and practice standards set by institutional and regulatory bodies, including documenting required employee health and safety training.
• Comply with corporate compliance policies, codes of conduct, conflict of interest policies, and core values as defined by the institution.
• Adhere to all applicable federal, state, and institutional regulations, laws, and policies, including completion of mandatory educational activities.

Essential Skills

• Current license to practice as a registered nurse in the State of New Jersey.
• Graduate of an accredited school of nursing.
• One (1) year of oncology nursing experience.
• One (1) to three (3) years of clinical research coordinator or clinical research experience, preferably in oncology.
• Demonstrated experience in screening, recruiting, enrolling, and coordinating patients on clinical trials.
• Experience and comfort communicating directly with patients about clinical trials, procedures, and care plans.
• Proficiency in conducting and documenting informed consent in accordance with IRB, GCP, and institutional policies.
• Ability to review medical records and source documents to determine protocol eligibility.
• Competence in coordinating and executing protocol-specific orders, tests, and appointments across care settings.
• Strong organizational skills with attention to detail in managing study tools, documentation, and research records.
• Proficiency with clinical and research computer applications and electronic medical records.
• Active Basic Life Support (BLS) certification.
• Strong communication and interpersonal skills to collaborate effectively with multidisciplinary teams and patients.
• Ability to interpret and apply regulatory requirements and institutional policies to daily research practice.

Additional Skills & Qualifications

• 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.
• Familiarity with clinical trial management systems, including OnCore and other institutional platforms.
• Experience with completion of Serious Adverse Event reports and adverse event grading using NCI criteria.
• Ability to provide teaching, orientation, and preceptorship to other staff and faculty involved in clinical research.
• Demonstrated ability to maximize available resources and work resourcefully in a complex academic medical environment.
• Comfort working with multiple concurrent trials and complex protocols across all phases of research.
• Willingness to pursue and maintain professional certifications and continuing education in oncology and clinical research.
• Equivalent combinations of education, experience, and training may be considered in place of formal degree preferences.

Work Environment

The position is based within an NCI-designated cancer center that operates as part of a large, integrated academic health system. The research program supports