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, outs... more details
Stanford University, Department Pediatrics, Division of Infectious Diseases is seeking a part time (50%) 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 includethe 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 studydata.
Duties include:
·Ensure the safety of study participants, and maintain communication with their families/caregivers andclinicians.
·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 writtenprotocols.
·Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and studyprotocols.
·Assess, grade, and document adverse events; apply triage and judgment to determine course ofaction.
·Oversee and, as needed, administer medications and treatments per study protocol and scope ofpractice.
·Complywithinstitutionalpolicies,standardoperatingprocedures,andguidelines;prepareandsubmitdocumentationas required by the study protocol and study sponsor; interpret complex protocols and regulatoryrequirements.
·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, asneeded.
·Support sponsor investigator research with investigational new drug/investigational device exemptionapplications.
- Other duties may also beassigned
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 between $52,600 to $78,490 based on commensurate experience and background.
DESIRED QUALIFICATIONS:
Knowledge of GCP, ICH and FDA regulatory (CFR Title 21 part312)
Experience overseeing outpatient clinical research studies
NPFlicensure
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 supportstaff
Demonstrated understanding of good clinical practices and regulatorycompliance.
Demonstrated ability to perform the functions of the position with minimalsupervision.
Verbalandwrittencommunicationskillstoconveymedicalandresearch-relatedinformationtoresearchsubjectsofallages and backgrounds.
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 perform the required study protocol documentation to record theseactivities
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 FurnishingNumber
Current basic CPRcertification.
PHYSICAL REQUIREMENTS*:
·Frequentlystand/walk,sit,performdesk-basedcomputertasks,twist/bend/stoop/squat,grasplightly/finemanipulation,use a telephone, write by hand, and sort/file paperwork orparts.
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 daylight hours.
*-Consistentwithitsobligationsunderthelaw,theUniversitywillprovidereasonableaccommodationtoanyemployeewitha disability who requires accommodation to perform the essential functions of his or herjob.
Occasional travel for research meetings and conferences likely
~ 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. ~
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