Description/Job Summary Introduction
The Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) requires a registered nurse for collaboration with the Department of Defense (DoD) to evaluate adverse events following
use of vaccine and/or other biological products in the military population.
Since the mass vaccination against the swine influenza outbreak in the U.S. in 1976, rare, serious adverse events following vaccination have become of increasing concern. On June II, 2009, the World Health Organization declared a global HINI influenza pandemic
based on the sustained worldwide spread of the virus. Since October, 2009, DoD has been using several HINI vaccines. To evaluate the safety of the novel HINI vaccine(s) in the military population, FDA collaborated with DoD and Centers for Disease Control
and Prevention (CDC) in large scale epidemiological research to identify adverse events following administration of HI N I vaccine in the active duty personnel. This collaboration is expected to be extended to include other vaccines and/or biological products
that are currently used or have potential to be used in the military population.
The scope of work is for the clinical review and evaluation of adverse events, by a public health registered nurse or a registered nurse epidemiologist, for vaccine or other biological product safety research in the military population. The overall project
will not exceed 1920 hours per year.
Qualifications of Registered Nurse
RN with BSN degree.
Minimum of 5 years of experience in Nursing.
Minimum of 1 year of experience in reviewing medical records.
Experience in public health (e.g. chart review and chart abstraction for population based studies), with an emphasis in epidemiology preferred.
Active nursing license anywhere in the Unites States.
I. Maintain confidentiality of personal health and identifying information of cases.
2. Maintain current HIPAA training and other required certifications.
3. Review electronic health records, verify diagnoses, and complete case abstraction form.
Follow up with clinical personnel involved in the care of the patient to obtain additional details for case verification (necessity to be negotiated on a case-by-case basis).
4. Adjudicate and summarize medical cases and present findings to DoD and FDA
5. Participate in project related one-hour meetings at DoD and FDA to discuss the progress
and issues relevant to health record review adjudication and abstraction forms, as needed.
7. Additional duties shall include one or both of the following:
a.) Search and review medical literature relevant to potential safety concerns
b.) Assist subject matter experts in development of case abstraction forms, case
definitions, and case identification algorithm(s)