Clinical Research Nurse Coordinator

About the role

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.
• Care for study patients in person or by phone and direct them 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.
• 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.

Qualifications

• 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.
• 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.

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 approximately 300 active trials with about 1,000 active subjects and a long-term goal of 2,500, enrolling around 5,000 subjects per year across Newark and multiple satellite sites throughout the state. Clinical operations include disease-specific groups such as breast, lung, phase I, and gastrointestinal oncology, supported by dedicated teams in research administration, quality assurance, informatics, education, and finance. The environment emphasizes scientific discovery, transdisciplinary collaboration, and rapid translation of laboratory findings into clinical studies, with a strong focus on patient-centered care, cancer prevention, and development of new therapies. Clinical research nurses work closely with physicians, coordinators, and ancillary departments in both adult and pediatric trials across all phases. The role involves frequent use of electronic medical records, clinical trial management systems, and other institutional applications to support documentation, scheduling, and regulatory compliance. Staff participate in ongoing training, quality initiatives, and interdisciplinary meetings, contributing to a culture of continuous improvement, education, and high standards of regulatory and ethical conduct.