Clinical Research Nurse Coordinator

About the role

We are seeking a Clinical Research Nurse to play a pivotal role in the activation and management of clinical trials. You will work collaboratively with a multidisciplinary team to ensure the safe, effective, and patient-centered conduct of clinical trials. This role involves the initiation, coordination, and management of protocols, as well as providing essential nursing care and education to patients enrolled in clinical trials.

Responsibilities

• Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols.
• Prepare and review study tools, such as study binders, medication diaries, eligibility checklists, and flow sheets.
• Verify approvals from the Scientific Review Board (SRB), Institutional Review Board (IRB), and ensure data collection plans and finance/contract approvals are in place prior to study activation.
• Review protocols and collect feedback to identify and resolve potential obstacles in study conduct.
• Educate nursing and other disciplines on protocol-related information to ensure safe and effective patient care.
• Translate protocol treatment plans and study calendars into sample orders.
• Collaborate with the clinical research team for timely prescreening of potential subjects for clinical trials.
• Review patient charts and medical history to confirm protocol eligibility.
• Obtain informed consent for both therapeutic and non-therapeutic studies in accordance with IRB and institutional policies.
• Provide support for registering research patients with study sponsors and input data into the clinical trials database.
• Serve as a resource for Clinical Trial Billing Information and coordinate patient reimbursement while on trial.
• Coordinate and deliver high-quality oncology nursing care as per protocol requirements.
• Accurately grade adverse events and document toxicities using NCI criteria or protocol-specific scales.
• Complete Serious/Unexpected Adverse Event (SAE) forms and ensure accurate follow-up reports.
• Assess protocol compliance and assist with deviation reporting as needed.
• Collaborate with the Clinical Trial Lab to ensure proper collection and processing of bio-specimens.
• Assist with monitoring visits, audits, and sponsor queries.
• Maintain accurate and complete nursing documentation for protocol-specified visits.
• Collaborate with medical system staff to ensure timely delivery of services to patients.
• Ensure accurate protocol-specific order execution, scheduling, and completion of tests and appointments.
• Care for study patients by coordinating continuity of protocol-specified procedures and treatments.
• Maintain research records for screened and enrolled patients.

Essential Skills

• Graduate of an accredited school of nursing with a license to practice in New Jersey.
• Bachelor’s Degree in Nursing preferred.
• One year of oncology experience required.
• Three to five 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 as a Clinical Research Analyst (CRA) or Clinical Research Professional (CCRP) preferred.
• Detail-oriented with excellent organizational skills.
• Proficient in computer applications such as Word and Excel.
• Excellent communication and interpersonal skills.

Additional Skills & Qualifications

• Experience as a Clinical Research Coordinator.
• Comfortable communicating with patients.
• Familiarity with clinical research and oncology practices.
• Knowledge of FDA, IRB, and GCP regulations.