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A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of New Drugs/ Office of Infectious Diseases (OID) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Currently, the primary endpoint for complicated urinary tract infection (cUTI) trials is a composite of clinical and microbiologic outcomes assessed at a fixed time point after completing therapy. In recent clinical trials, it has been noted that while some patients are classified as microbiologic failures due to persistently positive urine culture, however they are doing well clinically such that no further antibacterial therapy is needed. The reasons for this discordance are unclear and need further evaluation. In this project, data from recently completed cUTI trials will be reviewed to assess the degree of discordance between the clinical and microbiologic endpoints, the reasons for the discordance and, based on the data, consideration willgiven to revising the endpoint if needed.
Under the guidance of a mentor the participant will gain an understanding of the multi-year Combatting Antibiotic Resistant Bacteria Research Program that supports antimicrobial drug research as well as the development of new antimicrobial drugs and relevant aspects of drug regulation in the U.S. Participant will be training in various tools, methods, and study designs used to evaluate antimicrobial drug products. In addition, the participant will learn about cUTI trials and clinical and microbiologic endpoints.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Knowledge in clinical microbiology, epidemiology, and database development and validation, data mining, and data analyses is preferred.