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 andclinicians.

•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- sitestudies.

•Conductstudyparticipantevaluationsaccordingtothestudyprotocol,assess adverseevents,andapplytriageandjudgment to determine course ofaction.

•Administer medications and treatments per study protocol for out study participant research participants. May collect, process, and ship labspecimens.

•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 HIPAAguidelines.

•Supervise research staff, coordinating staffing or scheduling assignments asneeded.

•Participate in budget preparation and billingreconciliation.

•Identify, recruit, and enroll study participants. Participate in the informed consentprocess.

•Participate and host monitorvisits.

•Assist sponsor investigator research with Investigational New Drug/Investigational Device Exemptionapplications.

- Other duties may also be assigned

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

DESIRED QUALIFICATIONS:

•Experience in Bone Marrow transplant, genetics, oncology orhematology

•Clinical Researchexperience

•Excellent interpersonal communication, organizational skills, and ability to problem solve andmulti-task.

•Demonstrated knowledge of participation in a multi-disciplinary team is highlydesirable

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in nursing or equivalent, and two years of experience in nursing, preferably in a research setting.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

•Demonstrated ability to work with research subjects of all ages andbackgrounds.

•Verbalandwrittencommunicationskillstoconveymedicalandresearch-relatedinformation toresearchsubjectsofallages andbackgrounds.

•Ability to identify confidential and sensitive information (written andverbal).

•Ability to implement good clinical practices in all interactions with study participants, their families, andcolleagues.

•Ability to identify adverse reactions to study treatments and the required study protocol documentation to record these activities.

•Ability to implement study protocols withsupervision.

•Ability to provide work direction to research supportstaff.

•Demonstrated understanding of good clinical practices and regulatorycompliance.

•Demonstrated experience with electronic data capture, including databasemanagement.

•Demonstrated ability to perform the functions of the position with somesupervision.

CERTIFICATIONS & LICENSES:

•Current license as a California RegisteredNurse.

•Current basic CPRcertification.

PHYSICAL REQUIREMENTS*:

•Frequently stand/walk, sit, perform desk-based computer tasks, use a telephone, writing by hand, sort/file paperworkor parts, twist/bend/stoop/squat, and grasp lightly/fine manipulation.

•Occasionally reach/work above shoulders, grasp forcefully, operate foot and/or handcontrols.

•Rarely kneel/crawl, climb (ladders, scaffolds, or other), scrub/sweep/mop/chop/mix, operate a manualpipette.

•Ability to obtain and maintain a valid California non-commercial class license and operate vehicle during daylighthours

*-Consistentwithitsobligationsunderthelaw,theUniversitywillprovide reasonableaccommodationtoanyemployeewitha disability who requires accommodation to perform the essential functions of his or herjob.

WORKING CONDITIONS:

•May be required to work with, take specific precautions against, and/or be immunized against potentially hazardousagents.

•May be exposed to blood bornepathogens.

•On call 24hours/day.

•Frequent travel, might include internationaltravel.