Job Description

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 bachelor's degree and related master's degree may be considered in lieu of experience

• 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.
• Training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation. 

Classified Title: Sr. Research Nurse 
Role/Level/Range: ACRP/04/MF  
Starting Salary Range: $75,100 - $131,700 Annually ($102,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M - F 8:30a - 5p 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ???????SOM DOM Rheumatology  
Personnel area: School of Medicine 

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal ... timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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