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FDA CURE Pregnancy Treatment Repository Fellowship

*Applications will be reviewed on a rolling-basis.
Two research opportunities are currently available with the Office of the Commissioner (OC) Office of Women's Health (OWH), U.S. Food and Drug Administration (FDA). The project will be located at the Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland.
Due to concerns for maternal and fetal safety, pregnant women have historically been absent from clinical trials, there by leaving very few drugs approved for this patient population. Since pregnant women are usually not included in clinical trials, there is either no or limited data to support the safety of a drug taken during pregnancy. Pregnant women, however, need to manage acute and chronic health conditions during pregnancy. Drugs are prescribed to pregnant women, but their effects are not always known as that data is not systematically collected. It is important to collect the clinical data regarding drugs taken during pregnancy as it can aid in tracking drug outcomes and adverse events which in turn is used to help update safety information. The FDA encourages pregnant women to participate in pregnancy registries that track the outcomes from drugs taken while pregnant. FDA and NCATS/NIH have built a mobile application and website called CURE ID to capture the experiences of clinicians around the globe when they find novel ways of using FDA approved drugs to treat infectious diseases, emerging threats and multidrug resistant organisms.
With the help of the Office of Women’s Health grant, we are proposing to expand our program to collect data on the use of drugs for infectious diseases and cancer among pregnant women. The CURE Pregnancy Treatment Repository application will gather data on drugs used during pregnancy to expand our knowledge about their effects in pregnant women.
Under the guidance of a mentor, the participant will have the opportunity to learn about infectious disease and oncology in pregnant women, clinical trial data, health communications and research efforts to expand knowledge about the effects of drugs used during pregnancy.
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.
Qualifications
The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.OC.other@orau.org. Please include the reference code for this opportunity (FDA-OWH-2020-0007) in your email.