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 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.

Duties include:

·        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

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.