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

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

The Cell and Gene Therapy Research Nurse III is responsible for providing direct patient care and clinical support for patients enrolled in cell therapy and gene therapy clinical trials. This role requires expertise in managing complex advanced therapeutic modalities including CAR-T cell therapies, other cell therapies, and gene therapies.

This position encompasses intensive patient safety monitoring for therapy-specific adverse events including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), coordinating all aspects of cell & gene therapy protocols from screening through post-treatment follow-up, managing specialized care delivery including pre-infusion preparations and apheresis procedures, delivering comprehensive patient and family education on complex cell and gene therapies, and collaborating with clinical cell therapy/disease based teams, apheresis staff, cell therapy laboratories, pharmaceutical sponsors, and regulatory personnel.

Responsibilities include, but are not limited to:

• 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.
• Conduct specialized patient education on complex cellular and genetic therapies.
• Manage patient medication reconciliation and prescription renewals.
• Triage acute clinical issues specific to advanced therapy toxicities.

• 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).

• Assist with pre-certifications and prior authorizations for cellular therapies and gene therapy procedures.
• Coordinate 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.

• 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.

• 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.
• Active participation in Cellular Therapy Program committees.
• Develop and implement quality improvement projects for cellular therapy patient safety.
• Coordinates coverage for complex cellular therapy protocols o Serves as instructor, preceptor & mentor for advanced therapy nursing practices o Must achieve and maintain nursing career ladder requirements for level III.
• Perform other duties as assigned.

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.

Equal Opportunity Employer / Disability / Veteran

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