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Stanford University, Department of Medicine 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 delegated responsibilities. Oversee study conduct and assure study participant safety.  Coordinate and manage care for participants enrolled in a clinical research trail at the Sean N. Parker Center for Allergy and Asthma Research. Under the direction of the Medical Director, Clinical Director and Center Manager for Clinical Research, 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 implemented at the Center. 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, diagnose and treat medical conditions such as allergic reactions and anaphylaxis during study drug administration, exacerbations of asthma or other allergic conditions, formulate and evaluate treatment plans, manage common conditions such as allergic rhinitis, asthma and eczema, review home diaries and 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

DESIRED QUALIFICATIONS:
  • Knowledge of GCP, ICH and FDA regulatory (CFR Title 21 part 312)
  • Expertise with children with food allergies
  • NPF licensure

EDUCATION & EXPERIENCE (REQUIRED):
  • Bachelor's degree in nursing 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.
  • 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 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.

DESIRED QUALIFICATIONS:
  • Knowledge of GCP, ICH and FDA regulatory (CFR Title 21 part 312)
  • Expertise with children with food allergies
  • NPF licensure

PHYSICAL REQUIREMENTS*:
  • 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.

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.

WORK STANDARDS:
  • 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.
Job Family: Research
Job Series: Nurse Practitioner-Research
Job Code: 4568
Grade: K
Exemption: Exempt
Schedule: Full-time

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