Sr. Research Nurse

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

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.

Minimum Qualifications

• 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

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.
• 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

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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