Grade: J
As part of the new Stanford University Center for Definitive and Curative Medicine (CDCM), the Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) provides comprehensive project support and clinical trial management resources to Stanford Investigators specializing in cellular and gene therapies. The SCGT-CTO is seeking a Research Nurse 1 to work on novel cell and gene therapy clinical trials. S/he will be under the direction of the Clinical Trials Program Director, applying medical knowledge and experience to oversee and direct clinical course of participants in clinical trials or evidence-based treatment protocols. The SCGT- CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
Duties include:
• Support the safety of study participants, and maintain communication with their families/caregivers and clinicians.
• Provide clinical and administrative nursing support for research clinical trials based on scope of practice. Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and study protocols. May coordinate multi- site studies.
• Conduct study participant evaluations according to the study protocol, assess adverse events, and apply triage and judgment to determine course of action.
• Administer medications and treatments per study protocol for out study participant research participants. May collect, process, and ship lab specimens.
• Comply with institutional policies, standard operating procedures, and guidelines, and prepare and submit documentation as required by the study protocol, study sponsor, and regulatory authorities. Manage essential regulatory documents and handle confidential information (verbal and written) with tact and diplomacy, adhering to all HIPAA guidelines.
• Supervise research staff, coordinating staffing or scheduling assignments as needed.
• Participate in budget preparation and billing reconciliation.
• Identify, recruit, and enroll study participants. Participate in the informed consent process.
• Participate and host monitor visits.
• Assist sponsor investigator research with Investigational New Drug/Investigational Device Exemption applications.
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.
Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $110,743.00 to $141,084.00
• Experience in Bone Marrow transplant, genetics, oncology or hematology
• Clinical Research experience
• Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
• Demonstrated knowledge of participation in a multi-disciplinary team is highly desirable
Bachelor's degree in nursing or equivalent, and two years of experience in nursing, preferably in a research setting.
• Demonstrated ability to work with research subjects of all ages and backgrounds.
• Verbal and written communication skills to convey medical and research-related information to research subjects of all ages and backgrounds.
• Ability to identify confidential and sensitive information (written and verbal).
• Ability to implement good clinical practices in all interactions with study participants, their families, and colleagues.
• Ability to identify adverse reactions to study treatments and the required study protocol documentation to record these activities.
• Ability to implement study protocols with supervision.
• Ability to provide work direction to research support staff.
• Demonstrated understanding of good clinical practices and regulatory compliance.
• Demonstrated experience with electronic data capture, including database management.
• Demonstrated ability to perform the functions of the position with some supervision.
• Current license as a California Registered Nurse.
• Current basic CPR certification.
• Occasionally reach/work above shoulders, grasp forcefully, operate foot and/or hand controls.
• Rarely kneel/crawl, climb (ladders, scaffolds, or other), scrub/sweep/mop/chop/mix, operate a manual pipette.
• Ability to obtain and maintain a valid California non-commercial class license and operate vehicle during daylight hours
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:
• May be required to work with, take specific precautions against, and/or be immunized against potentially hazardous agents.
• May be exposed to blood borne pathogens.
• On call 24 hours/day.
• Frequent travel, might include international travel.
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