Clinical Research Nurse Coordinator

Clinical Research Nurse

The primary purpose of the Clinical Research Nurse role is to ensure the successful, patient-oriented, safe, and effective conduct of clinical trials. This position assists investigators in preparing and implementing new clinical trials, screens and enrolls study participants, and provides protocol-related clinical management to participants while on study.

Responsibilities:

• Collaborate with Protocol Activation office to initiate and activate 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 and resolve potential obstacles to safe and effective study conduct.
• Provide protocol-related nursing education to other disciplines to facilitate 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 review patient charts and medical history to confirm protocol eligibility.
• Obtain informed consent for therapeutic and non-therapeutic studies in accordance with IRB, GCP, and institutional policies and procedures.
• Register consented research patients with study sponsors and input data into the OnCore® clinical trials database.
• Serve as an essential link between patients and research team members, ensuring protocol-specific orders are entered and executed accurately.
• Coordinate continuity of protocol-specified procedures and treatments for study patients across disciplines and sites of care.
• Manage patient reimbursement while on clinical trial, including the use of Rutgers issued or study-specific Clin Cards.
• Deliver high-quality, compassionate oncology nursing care and coordinate with clinical team, investigators, and ancillary departments as per protocol requirements.
• Provide nursing assessment of study patients and document complete and accurate protocol-specified visits.
• Collaborate with medical system staff to ensure timely coordination and delivery of services to patients.
• Accurately grade adverse events and document toxicities using protocol-specific grading scales.
• Complete Serious/Unexpected Adverse Event (SAE) forms and ensure accurate follow-up reports.
• Assess overall protocol compliance and assist with deviation reporting according to IRB guidelines.
• Collaborate with the Clinical Trial Lab to ensure study-specific bio-specimens are collected and processed according to protocol guidelines.
• Assist with monitoring visits and audits, providing accurate and timely responses to sponsor queries.
• Complete Case Report Forms (CRFs) and resolve database queries as needed.
• Maintain research records for screened and enrolled patients.
• Role model high levels of professional responsibility and performance.
• Strive for professional growth through continuing education and skill building.
• Demonstrate competence in utilizing computerized systems required for research tasks.

Essential

Skills:

• Graduate of an accredited school of nursing with a license to practice in the State of New Jersey.
• Bachelor's Degree in Nursing preferred.
• One year of oncology experience required.
• Three to five years of oncology research experience preferred.
• Basic Life Support (BLS) certification.
• Oncology Nursing Society (ONS) certification as an Oncology Certified Nurse (OCN) or Advanced Oncology Certified Nurse (AOCN) preferred.
• Association of Clinical Research Professional as a Clinical Research Analyst (CRA) or Society of Clinical Research Associates (SoCRA) certification as a Clinical Research Professional (CCRP) preferred.
• Detail-oriented with excellent organizational skills.
• Proficiency in computer applications such as Word, Excel, etc.
• Excellent communication and interpersonal skills.

Additional Skills &

Qualifications:

• Experience and comfortability communicating with patients.
• Clinical Research Coordinator experience required.
• Knowledge in oncology, informed consent processes, recruiting, enrolling, and managing source documents.
• Screening of patients and coordination of study experience.
• Equivalent education, experience, and training may be substituted for the degree requirement.

Work Environment:

The work environment is within a statewide, national, and world-leading scientific discovery center focused on improving cancer outcomes. The center conducts innovative basic, clinical, and population research alongside cutting-edge patient-centered care. The position is part of a large clinical operations team with disease-specific groups, contributing to high enrollment needs across multiple sites, including Newark and other locations. The center is involved in all phases of clinical…