Sr. Research Nurse
The Department of Medicine, Division of Rheumatology is seeking a Sr. Research Nurse, ideally having certification as an Oncology Certified Nurse (OCN) and/or Blood and Marrow Transplant Certified Nurse (BMTCN), with prior work experience in adoptive cellular therapy and/or bone marrow transplantation to support early-phase clinical trials using CAR-T cells, other engineered cellular therapies, and antibody-based therapies for the treatment of patients with various severe autoimmune and rheumatic diseases. This position will expand the capabilities for cellular therapies at Johns Hopkins Hospital for non-oncological indications and will include work in the Clinical Research Units at Johns Hopkins Hospital, including the Inpatient and Outpatient Clinical Research Units on Nelson 5 and Blalock 3.
Diagnoses of patients treated will include patients with rheumatic and autoimmune diseases such as systemic lupus erythematosus (SLE), autoimmune muscle disease/myositis, scleroderma, vasculitis, Sjgren's disease, and other organ-specific autoimmune diseases that receive care at the different Centers of Excellence at Johns Hopkins.
Nurses will attend training by our experienced cell therapy nurses in oncology to administer lymphodepletion therapy (e.g., cyclophosphamide, fludarabine) as well as cell therapy and antibody products, will be trained in the recognition and management of cytokine-related adverse events (e.g., CRS, ICANS, cytopenia), and in the care of patients with rheumatic disease in general. There are extensive opportunities for growth and development in this new, and rapidly growing space of cell therapy for autoimmune diseases through continued education opportunities and lectures in the Division of Rheumatology and oncology. The position will combine the dedicated care of patients that are enrolled in clinical trials throughout their treatment journey (inpatient and outpatient), the coordination of research trial activities (screening of patients, supporting consent, education and training of trial participants) in a multidisciplinary team of rheumatologists, nephrologists, and oncologists and other sub-specialists.
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, the successful candidate will oversee day-to-day clinical research operations and study initiation in partnership with the team.
- Duties include assisting with the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
- Overall responsibilities for the CAR T-cell position cover the areas of 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.
- Interacts 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.
- Assures required research activities and associated compliance metrics are documented in compliances with FACT requirements specific to these therapies
- Collaborates 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.
- Documents and maintains safety and toxicity records for each CAR T-cell infusion, prepare reports and conducts CAR T-cell specific clinical performance improvement meetings.
- Collaborates with clinicians, nurses, nurse practitioners to assure inpatient/outpatient infusion orders are built per package insert and trial protocol requirements.
- Determines recruitment strategy, progress, timeline, and work plan to manage research study operations.
- Performs 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.
- Assists 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.
- Creates and utilizes patient education materials for commercial CAR-T cell therapy.
- Creates and utilizes 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.
- Maintains and updates pre-CAR-T cell medical records, files documents, data-entry into database.
- Collaborates with clinicians, nurses, nurse practitioners to assure inpatient lymphodepleting and infusion orders are built per trial or protocol requirements.
- Serves as the lead contact for all commercial CAR-T cell audits and site visits. Responds with assistance from the Quality Coordinator to any audit or site visit results.
- Guides and mentor's junior staff. Facilitates communications with the principal investigator, study sponsor, and department administration.
- Performs other related duties as assigned.
Additional Knowledge, Skills, & Abilities
- Knowledge of key practices in the field as well as all relevant federal, state, local laws, regulations, and policies.
- Skill in ethically communicating risks and benefits.
- Skill in meeting multiple priorities and studies in various stages of development.
Physical Requirements
- Sitting/standing in normal position for extended periods of time.
- Ability to use a keyboard and move about.
- Ability to see and hear within normal parameters.
- Walking between buildings, pulling a cart.
Minimum Qualifications
- Individual must be a registered Nurse, licensed in the State of Maryland or state where practicing.
- Bachelor's Degree in Nursing or related discipline required.
- Minimum of two years' experience in the specialty or a related area required.
- Additional experience may substitute for bachelor's degree. Related master's Degree may be considered in lieu of experience.
Preferred Qualifications
- Master's Degree strongly preferred.
- Oncology Certified Nurse (OCN) and/or Blood and Marrow Transplant Certified Nurse (BMTCN)
- Certification from Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
- Comprehensive knowledge of research principles and practices preferred.
- Skill in assurance of participant care preferred.
Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $74,400 - $130,400 Annually ($102,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 - 5
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Rheumatology
Personnel area: School of Medicine