Cell and Gene Therapy Research Nurse III - Cell Engineering & Therapy

Responsibilities

• Conduct informed consent for complex cell and gene therapy protocols.
• Attend and/or perform research visits for cell & gene therapy studies.
• Perform/review required protocol assessments including pre-treatment/infusion evaluations.
• Monitor patients for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and other cell/gene therapy-related adverse events.
• Oversee apheresis procedures and cell collection processes.
• Monitor patient responses during and post-cell/gene therapy administration with intensive safety monitoring.
• Deliver comprehensive patient and family education on complex cellular and genetic therapies.
• Manage patient medication reconciliation and prescription renewals.
• Triage acute clinical issues specific to advanced therapy toxicities.

Documentation

• Responsible for timely research nursing documentation per Cell and Gene Therapy Standard Operating Procedures (SOP).
• Facilitate cell therapy product preparation, coordination, and verification of document specialized assessments for cellular therapy monitoring (neurological, cardiac, laboratory).

Administrative

• Aid with pre-certifications and prior authorizations for cellular therapies and gene therapy procedures.
• Collaborate with cell therapy laboratories and investigational product manufacturers.
• Maintain comprehensive knowledge of study protocol requirements, institutional guidelines, and standard operating procedures (SOPs) to ensure compliance.
• Identify and reconcile any discrepancies between protocol requirements and institutional policies, escalating issues as appropriate to maintain study integrity and patient safety.

Required Meetings

• Cell and Gene Therapy team meetings.
• Cellular Therapy Program committees.
• Sponsor Investigator meetings.
• Site Initiation Visits (SIVs) for advanced therapy protocols.
• Self-directed review of new cell and gene therapy protocols and reeducation on existing therapies.

Training

• Completing specialized training in cellular therapy and gene therapy nursing care and guidelines.
• Creating and providing cell & gene therapy-related in-services for Infusion Staff on CRS management, neurological monitoring, and specialized infusion procedures.
• Serves as a role model and clinical expert in cellular and gene therapy nursing.
• Serves as a Clinical Resource for cell and gene therapy protocols.
• Primary role in orientation and continuing education for cell and gene therapy nursing competencies.
• Designs/Creates learning experiences focused on cell and gene therapy nursing care.
• Coordinates coverage for complex cellular therapy protocols.
• Serves as instructor, preceptor & mentor for advanced therapy nursing practices.
• Must achieve and maintain nursing career ladder requirements for level III.

Minimum Qualifications

• Bachelor of Science in Nursing or completed Accelerated Program in Nursing.
• NYS RN License.
• 4 years of cell therapy, gene therapy, or hematologic malignancy research nursing experience in clinical trials.
• Experience with CAR-T cell therapy, cellular immunotherapies, or gene therapy protocols.
• Knowledge of cytokine release syndrome and neurological toxicity management.
• HIPAA, Good Clinical Practice (GCP), and Conflict of Interest (COI) training certification required upon hire.
• Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple clinical trials.
• Excellent interpersonal and organizational skills for managing complex patient populations.
• BLS or ACLS certification from a nationally recognized organization.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Teams, OneDrive, and SharePoint.

Preferred Qualifications

• OCN/AOCNP, BMTCN, or cellular therapy nursing certification; CCRP/CCRC certification; FACT Immune Effector Cell training.
• Supervisory or leadership experience with clinical research staff.
• Experience supporting cell and gene therapy clinical trials or complex biologics studies.
• Familiarity with Columbia University research and clinical systems.

Other Requirements

• Medical clearance and participation in the medical surveillance program.
• Direct patient contact and/or interaction with human research subjects.
• Use of N-95 respirator as needed.
• Potential exposure to bloodborne pathogens.
• Successful completion of all required compliance and systems training.