Clinical Research Nurse Coordinator

Job Title:

Clinical Research Nurse

The primary purpose of the Clinical Research Nurse is to ensure the successful, patient-oriented, safe, and effective conduct of clinical trials. This role involves assisting investigators in preparing and implementing new clinical trials, screening and enrolling study participants, and providing protocol-related clinical management to those participants while on study.

• Collaborate with the Protocol Activation office to initiate and activate all new clinical trial protocols using the Study-start up task list.
• Prepare and review study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
• Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation.
• Review protocols and collect multidisciplinary logistical, educational, and financial feedback to identify potential obstacles to study conduct.
• Perform nursing education to other disciplines for safe, effective care of enrolled patients.
• Translate finalized protocol treatment plans into sample orders.
• Ensure timely prescreening of potential subjects and active cancer patients for clinical trials.
• Review patient charts and medical history to confirm protocol eligibility and obtain source documents.
• Follow informed consent processes to ensure that IRB approved consent has been obtained and documented.
• Provide backup support to register consented research patients and input data into clinical trials database.
• Serve as a resource for Clinical Trial Billing Information.
• Coordinate protocol-specified procedures and treatments for study patients across disciplines/sites of care.
• Manage patient reimbursement while on clinical trial and coordinate hands-on oncology nursing care.
• Provide nursing assessment and documentation for study patients, ensuring accurate protocol adherence.
• Collaborate with medical staff to ensure timely delivery of services to patients.
• Grade adverse events and document toxicities as per protocol requirements.
• Complete Serious/Unexpected Adverse Event (SAE) forms and ensure follow-up reports are accurate.
• Assess overall protocol compliance and assist with deviation reporting.
• Ensure bio-specimens are collected and processed according to protocol guidelines.
• Assist with monitoring visits, audits, and sponsor queries.
• Maintain research records for screened and enrolled patients.
• Model professional responsibility and performance, and strive for professional growth.
• Demonstrate competence in utilizing computerized systems required for clinical tasks.
• Participate in training programs, quality assurance activities, and professional development.
• Ensure adherence to Institutional, State, and Federal regulations and maintain mandatory educational requirements.

• Bachelor’s Degree in Nursing preferred.
• License to practice nursing in the State of New Jersey.
• One (1) year of oncology experience required.
• Three (3) to five (5) years of oncology research experience preferred.
• Active Basic Life Support (BLS) certification.
• Oncology Nursing Society (ONS) certification as an Oncology Certified Nurse (OCN) or Advanced Oncology Certified Nurse (AOCN) preferred.
• Certification from the Association of Clinical Research Professionals as a Clinical Research Analyst (CRA) or Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional (CCRP) preferred.
• Proficiency in computer applications such as Word, Excel, etc.
• Excellent communication and interpersonal skills.

• Detail-oriented with excellent organizational skills.
• Experience and comfortability communicating with patients.
• Ability to maximize resources and be resourceful.
• Equivalent education, experience, and/or training may be substituted for the degree requirement.

The work environment involves being part of a statewide, national, and world leader of scientific discovery and patient care in cancer research. The role supports the conduct of innovative research and patient-centered care across various phases of trials, including adult and pediatric studies. The team operates at…