Clinical Research Nurse

Job Title:

Clinical Research Nurse Coordinator (Pediatrics)

Job Description

This role serves as a Research Nurse Clinician within a comprehensive oncology clinical trials program, with a focus on pediatric studies. The Clinical Research Nurse Coordinator ensures safe, effective, and patient-centered conduct of clinical trials by supporting protocol activation, screening and enrolling participants, and providing protocol-driven clinical management throughout the study. The position bridges direct patient care and research operations, working closely with investigators, multidisciplinary clinical teams, and research administration to maintain regulatory compliance, data integrity, and high-quality oncology nursing care.

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 Scientific Review Board, Institutional Review Board, data collection plans, and finance/contract approvals prior to study activation.

* Review protocols and gather multidisciplinary logistical, educational, and financial feedback to identify and resolve obstacles to safe and effective study conduct in collaboration with the Principal Investigator.

* Provide one-on-one and group protocol-related nursing education to other disciplines to support safe and effective care of enrolled patients.

* Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders.

* Work with the clinical research team to ensure timely prescreening of potential subjects and active cancer patients for available clinical trials.

* Review patient charts and medical histories to confirm protocol eligibility and obtain necessary source documents.

* Conduct the informed consent process in accordance with IRB, GCP, and institutional policies, ensuring consent is properly obtained, documented, and filed in the medical record.

* Obtain informed consent for both therapeutic and non-therapeutic studies as assigned and ensure patients receive copies of signed consent forms.

* Provide back-up support to register consented research patients with study sponsors and enter data into the OnCore clinical trials database.

* Complete precertification forms and provide anticipated clinical information to financial counselors, responding to payer queries and serving as a resource for clinical trial billing information based on the billing grid.

* Serve as a key liaison between patients and members of the research team, ensuring clear communication and coordination of care.

* Identify and communicate challenges related to protocol-required procedures or timelines to the study team and supervisor, and participate in problem-solving.

* Ensure protocol-specific orders are entered and executed accurately, including scheduling and completion of tests and appointments within and outside the health system, from eligibility work-up through end-of-study transition.

* Coordinate and oversee continuity of protocol-specified procedures and treatments across disciplines and sites of care, including inpatient needs related to the study protocol.

* Coordinate patient reimbursement while on clinical trials, including management of institutional or study-specific reimbursement cards.

* Deliver high-quality, compassionate, hands-on oncology nursing care in accordance with protocol requirements and GCP guidelines, collaborating with clinical teams, investigators, and ancillary departments such as pathology, radiology, laboratory, surgery, and infusion services.

* Conduct nursing assessments of study patients by phone or in person and route patients appropriately for additional or urgent care needs.

* Document nursing assessments and protocol-specific visits accurately using institutional templates, reconcile concomitant medications, and ensure clear communication regarding patients who are off treatment or off study.

* Collaborate with integrated academic medical system staff to coordinate timely services for patients…