*Although the application deadline is April 16th, mentors will start reviewing submitted applications before the deadline.
Summer research opportunities are available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER).
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER’s mission is to protect and promote health by helping to ensure that these human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients who need them.
Participants will have an opportunity to gain a hands-on research experience on a variety of regulatory research projects related to CDER’s mission. The program is designed for participants to engage with an expert mentor or mentors during the summer to examine a question of interest related to those projects within the placement office. Past projects have been related to: drug metabolism, bio-statistical questions, in-vitro models for drug toxicology, safety and efficacy, benefit-risk assessments, etc.
Both full-time and part-time appointments are typically available. Anticipated start day is on or around May 3, 2021, but can be negotiated with the mentor to commence on any Monday throughout the summer in order to best align with school and/or vacation schedules.
Based on pandemic response, participants may be able to participate from an alternate location on a temporary basis. However, at the time when Mentors and FDA Staff return to their usual on-site work schedule, participants will no longer be able to conduct training from an off-site location and will be expected to report to the site in Silver Spring, Maryland or St. Louis, Missouri.
To avoid conflict of interest, participants cannot be placed in the same CDER program office where a relative works.
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 2-3 months, 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 part-time or full-time at FDA in the Silver Spring, Maryland or St. Louis, Missouri areas. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0000) in your email.