Sr. Research Nurse

The Johns Hopkins University School of Medicine, Department of Rheumatology is seeking a cell-therapy experienced Sr. Research Nurse to lead and support the new CAR-T Cell Therapy Service for Rheumatic and Autoimmune Diseases.

Specific Duties & Responsibilities

Clinical Care Activities

• Administration of cellular therapy products at Johns Hopkins in coordination with Clinical Research Unit staff.
• Administration of chemotherapy/ lymphodepletion therapy and supportive medications in coordination with Clinical Research Unit staff.
• Care of patients with autoimmune diseases undergoing cellular and antibody-based immunotherapy including administration of other non-cell therapy drugs, transfusions of blood product, monitoring of cytokine-related toxicities (e.g., CRS, ICANS) and adverse events, symptom management, reviewing laboratory findings, and central line or other access management.

Clinical Research Activities

• Under the Director of the Cellular Therapy Program, oversee day-to-day clinical research operations and study initiation in partnership with the team.
• Assist with the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial.
• Collaborate with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
• Responsible for project development/coordination, quality and performance improvement activities with clinical staff and ancillary departments, regulatory/accreditation compliance oversight, integration of all clinical staff education required for compliance with the overall CAR T-cell program.
• Interact with study participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, patient education, and obtaining patient medical history.
• Collaborate with the clinical research team for all CAR T-cell clinical trials and assures required research activities and associated compliance metrics are documented in compliance specific to these therapies.
• Assure required research activities and associated compliance metrics are documented in compliances with FACT requirements specific to these therapies
• Collaborate with all ancillary staff, inpatient and outpatient, to assure safety training per manufacturer’s requirements per CAR T-cell product and replicating this for each product implemented.
• Maintain education records in compliance with, and perform all audits required by, the manufacturer for each CAR T-cell product.
• Document and maintain safety and toxicity records for each CAR T-cell infusion, prepare reports and conducts CAR T-cell specific clinical performance improvement meetings.
• Collaborate with clinicians, nurses, nurse practitioners to assure inpatient/outpatient infusion orders are built per package insert and trial protocol requirements.
• Determine recruitment strategy, progress, timeline, and work plan to manage research study operations.
• Perform day-to-day operational duties such as: ensuring quality control and safety compliance; serving as liaison with IRB and other institutional committees relevant to clinical trials; submitting invoicing; developing procedures; ordering supplies.
• Assist in monitoring resources such as examination room availability and use of on-call study staff, including assistance in monitoring a clinical trial, or unit budget and compliance.
• Create and utilize patient education materials for commercial CAR-T cell therapy.
• Create and utilize clinical education materials for commercial CAR-T cell therapy for MDs, APPs, RNs, social work, and other clinical team members.
• Ensure all clinical members are trained on each SOP.
• Maintain and update pre-CAR-T cell medical records, files documents, data-entry into database.
• Collaborate with clinicians, nurses, nurse practitioners to assure inpatient lymphodepleting and infusion orders are built per trial or protocol requirements.
• Serve as the lead contact for all commercial CAR-T cell audits and site visits.
• Respond with assistance from the Quality Coordinator to any audit or site visit results.
• Guide and mentor junior staff. Facilitate communications with the principal investigator, study sponsor, and department administration.
• Perform other related duties as assigned.

• Registered Nurse, licensed in the State of Maryland.
• Bachelor's degree in nursing or related discipline required. 
• Minimum of two year's experience in the specialty or a related area.
• Additional experience may substitute for bachel