Clinical Trials Nurse- Full Time

Job Type: Officer of Administration

Bargaining Unit:

Regular/Temporary: End Date if Temporary:

Building:

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The Division of Pediatric Hematology, Oncology, and Stem Cell Transplant at Columbia Children's Health, New York-Presbyterian Morgan Stanley Children's Hospital (MSCH) is one of the oldest and most comprehensive centers in the country focused on treating children with cancer and blood disorders. MSCH has 202 inpatient pediatric beds, including a 54-bed Pediatric Intensive Care Unit and 10 operating rooms. Our division is currently composed of 3 sections (Hematology, Oncology and Stem Cell Transplantation) with 22 full-time faculty, 3 research RN/NP's, 8 clinical research associates, and 3 regulatory specialists and includes an ACGME-accredited Fellowship Program and a FACT-accredited stem cell transplant program.

We are seeking a Nurse Practitioner to work in the Research Capacity to join our team in a full-time position within Oncology for Clinical Research focused on working on the Immuno-Oncology Program (PIRD).

Responsible for the coordination, oversight and administration of clinical research protocols.

Attend and/or perform all protocol required visits either independently or as a shared visit depending on treating physician's preference. Initial or restaging assessment visits must be performed with the treating physician.

Order and interpret radiology, laboratory, and diagnostic tests as appropriate.

Prescribe and manage supportive care medications.

Perform phone triage for acute clinical issues and conduct phone assessments as required per protocol and prescribe treatment as needed

Verify Study drug/Standard of Care orders if entered by another Physician Investigator/Fellow/NP.

Obtain pre-certifications and prior authorizations for procedures / prescriptions when requested.

Create and provide protocol-related in-services for both inpatient and outpatient Nursing Staff.

Filing serious adverse event reports and working with Clinical Research Coordinators to identify and classify serious adverse events.

Developing and overseeing a quality management plan. Oversees data reporting requirements to ensure consistent integration with existing institutional frameworks, including timely and accurate submission to CIBMTR and other designated data repositories. Ensures high-quality clinical trial data capture and reporting in alignment with operational standards and program expectation. Monitors clinical trial and treatment fidelity across sites of care, proactively identifying barriers to implementation and leading process improvement efforts.

Preparation of regulatory documents for IRB submission.

Serve as a liaison between PI's and study sponsors in both outpatient and inpatient areas;

Serves as a liaison with pharmacy and research pharmacy

Serves as subject matter expert in the planning and clinical execution of new cellular immunotherapy program and clinical trials.

Leads the design and operationalization of care pathways, workflows, and clinical infrastructure to support safe and effective delivery of cellular immunotherapy, with a focus on CAR T cell therapy.

Partners with physicians, clinical trial investigators, research teams, pharmacy, cell lab, apheresis, and hospital administration to ensure seamless coordination across all care and research touchpoints.

Functions as the central liaison between the cellular immunotherapy program and stakeholders including clinical operations, research administration, clinical trials office, and institutional leadership.

Develops and oversees operational workflows to support the onboarding of clinical trial protocols and commercial CAR T-cell therapies, ensuring clinical units, staff, and resources are consistently prepared for program execution. Oversees the integration of clinical workflows between outpatient infusion centers, inpatient units, and emergency/critical care teams to ensure continuity and safety

Facilitates weekly multi-disciplinary clinical operations (clin-ops) virtual meeting to align and update cellular immunotherapy clin-ops team: Including: Clinicians/study PIs, nurse coordinators, NPs/PAs, manufacturing team, regulatory team, CRCs, social work, pharmacy, with meeting open to CUMC peds onc/transplant team.

Ensure the Pediatric Translational Cellular Immunotherapy team is represented and engaged in high-level outreach and networking opportunities.

Collaborates with marketing to increase visibility of new clinical trials and develops outreach materials and resources for distribution to locoregional referring centers.

Metrics, and Performance Monitoring

Collaborates with research, informatics, and analytics teams to monitor and interpret clinical and operational data related to cellular immunotherapy outcomes, adverse events, and efficiency metrics.

Uses data to inform continuous improvements in workflow, throughput, and resource allocation.

Supports clinical trial compliance by ensuring nursing documentation aligns with protocol-driven requirements and supports accurate data capture.

Develops and implements education for clinical and research staff involved in cellular immunotherapy delivery.

Develops and oversees education material and support resources for patients and families presenting to CUMC for cellular immunotherapy delivery.

Provides mentorship and teaching to bedside nurses, research nurses, and coordinators involved in cellular immunotherapy trials and treatments.

Promotes clinical competency and preparedness across nursing teams through ongoing education, and shared learning.

Current New York State NP and RN License, maintain and renew when necessary (NP's are required to have a NYS license to qualify for the position) and ANCC Board Certification.

Able to function independently with minimal supervision.

University Policies)

Must successfully complete applicable compliance and systems training requirements.

EPIC Access Required.

Able to meet New York-Presbyterian Hospital credentialing requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.