Stanford University, Department Pediatrics, Division of Infectious Diseases is seeking a Nurse Practitioner – Research to apply medical knowledge and experience, under the direction of the principal investigator 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 and delegated responsibilities. Oversee study conduct and assure study participant safety. Coordinate and manage care for participants enrolled in a clinical research trail, responsibilities will include preparation and submission of protocol related documents and amendments to the IRB, FDA and Sponsors, identify and recruitment of participants, obtaining informed consent, management of protocol related finances to include the study workbook and ensure billing compliance, perform phlebotomies and insertion of IVs, perform skin prick tests, prepare and maintain source documentation for phase 1-3 studies. Participate in study design, communicate with families, participants referring physicians and other health care providers, teaching and advice to participants and families to ensure compliance and retention of study participants, tracking and recording of adverse events, perform physical exams to ensure enrollment criteria and to track for any changes during study participation, formulate and evaluate treatment plans, be available for on call advice and emergencies between clinic visits, administer rescue medications based on clinical judgment, write develop and maintain database of clinical trial information, assist in analysis of study data.
- Ensure the safety of study participants, and maintain communication with their families/caregivers and clinicians.
- Provide clinical and administrative medical support and oversight for research clinical trials based on scope of practice; obtain complete study participant history, conduct physical exams, review medical charts, assess findings, prescribe and re- fill medication, and perform designated procedures according to written protocols.
- Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and study protocols.
- Assess, grade, and document adverse events; apply triage and judgment to determine course of action.
- Oversee and, as needed, administer medications and treatments per study protocol and scope of practice.
- Comply with institutional policies, standard operating procedures, and guidelines; prepare and submit documentation as required by the study protocol and study sponsor; interpret complex protocols and regulatory requirements.
- Coordinate and collaborate with principal investigator to review study protocol; assess and analyze feasibility, budget projections, and staffing needs.
- Supervise and train non- clinical and clinical staff/students, as needed.
- Identify, recruit, and enroll study participants, as well as maintain study participant records; determine study participant criteria.
- Support sponsor investigator research with investigational new drug/investigational device exemption applications.
- - Other duties may also be assigned
- Knowledge of GCP, ICH and FDA regulatory (CFR Title 21 part 312)
- Experience overseeing outpatient clinical research studies
- NPF licensure
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree, Nurse Practitioner license and three years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Ability to provide work direction to research support staff.
- Demonstrated understanding of good clinical practices and regulatory compliance.
- Demonstrated ability to perform the functions of the position with minimal supervision.
- 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 perform the required study protocol documentation to record these activities.
- Ability to implement study protocols with minimal supervision
CERTIFICATIONS & LICENSES:
Licensed as a Registered Nurse by the California State Board of Registered Nursing. Certified as Nurse Practitioner by the California State Board of Registered Nursing. Must include a Nurse Practitioner Furnishing Number
- Current basic CPR certification.
- Frequently stand/walk, sit, perform desk-based computer tasks, twist/bend/stoop/squat, grasp lightly/fine manipulation, use a telephone, write by hand, and sort/file paperwork or parts.
- 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.
- 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.
- Occasional travel for research meetings and conferences likely
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
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