Research Nurse 2

The Stem Cell and Gene Therapy Clinical Trial Program (SCGT-CTP) in the Pediatric Division of Stem Cell Transplantation and Regenerative Medicine, Stanford University School of Medicine, is seeking a Research Nurse 2. S/he will be under the direction of the principal investigator, applying medical knowledge and experience to oversee and direct clinical course of research participants in clinical trials. Assess physical health and administer treatments throughout the study aligned with "Scope of Practice" delegated responsibilities. Oversee study conduct and ensure study participant safety.The SCGT-CTP 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.

The mission of the SCGT-CTP is to translate basic discoveries into innovative therapeutics to treat children with debilitating diseases for which there are no cures at present and the identification of curative therapies for such children will offer them new hope for health, improvement in their quality of life, and a reduction in medical costs compared to their present palliative, but not curative therapies.

Duties include:

• Ensure the safety of study participants, and maintain communication with their families/caregivers and clinicians.
• Provide clinical and administrative nursing support and oversight 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.
• Develop and manage budget for research study, and oversee resources including funds, personnel, and equipment as needed. Coordinate and collaborate with principal investigator to review study protocol and assess and analyze feasibility, budget projections, and staffing needs.
• Conduct study participant evaluations according to the study protocol, assess adverse events, and apply triage and judgment to determine course of action.
• Oversee and potentially administer medications and treatments per study protocol for out study participant research participants.
• 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. Interpret complex protocols and regulatory requirements. Oversee and manage essential regulatory documents and handle confidential information (verbal and written) with tact and diplomacy, adhering to all HIPAA guidelines.
• Supervise non-clinical research staff as needed.
• Identify, recruit, and enroll study participants, as well as maintain study participant records and determine study participant criteria.
• Host external audits (Food and Drug Administration, National Institutes of Health, etc.).
• Support sponsor investigator research with Investigational New Drug/Investigational Device Exemption applications.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in nursing or equivalent, and five years of experience in nursing, with at least two years in a research setting.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• 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 minimal supervision.
• Ability to provide work direction to research support staff.
• Demonstrate 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 minimal supervision.

CERTIFICATIONS & LICENSES:

• Current license as a California Registered Nurse.
• Certified Research Administrator or Clinical Research Coordinator preferred.
• Current basic CPR certification.

PHYSICAL REQUIREMENTS*:

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