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, and Clinical Director 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.
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
Internal Number: 285911
About Stanford University
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu.
Stanford University is a...n equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.