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Graduation Medical Education (GME): NIH-FDA Division of Neurology (DN) Clinical Trial Methodology and Regulatory Science Fellowship

Fellowship Program Directors:
Robin Conwit MD, NINDS
Heather Fitter, MD, CDER, FDA
Lauren Reoma, MD, NINDS

Overview
The NINDS Clinical Trials Unit, together with the Division of Neurology (DN), U.S. Food and Drug Administration (FDA), and the NINDS extramural Division of Clinical Research (DCR) are offering a Clinical Trial Methodology and Regulatory Science Fellowship. The two-year NIH-FDA fellowship, with the option for extension for an additional year, will include hands-on participation both in neurology clinical research conducted at the NIH Clinical Center in Bethesda, Maryland, and in neurology clinical research regulatory review at the FDA Federal Research Center in Silver Spring, Maryland. The Fellow will receive training in all aspects of clinical trials including concept evaluation, protocol development, statistical design, trial implementation, safety monitoring, ethical considerations, and regulatory sciences. During the first year, the emphasis will be on acquiring the basic skills necessary for the conduct of clinical research with most activities taking place at NIH along with early exposure to the FDA environment. During the second year, increasing independence in clinical research will be accompanied by more intensive participation in the full spectrum of activities in DN, ranging from pre-investigational discussions with clinical investigators about first-in-human drug trials to analysis of complicated multi-center trials leading to possible approval of new medical products. In addition, Fellows will engage in implementing a clinical research project at the NIH Clinical Center and participate in a weekly subspecialty clinic of their choice. The program is customized but generally will include coursework on clinical research methodology and statistics. This fellowship is suitable for neurologists or neurosurgeons with a strong interest in clinical research and is particularly suited to those who already have some research experience.

Application Information
NIH Graduate Medical Education Application

Also visit the NINDS intramural program website for more information.

We seek applicants planning careers in clinical neurology or neurosurgery and therapeutics development in academic medicine, government service, or other settings. Graduates of accredited residency programs or clinical fellows in neurology or neurosurgery in academia or at the NIH are encouraged to apply. Priority will be given to applicants who have identified an area of clinical interest in a given subspecialty or disease area and who have developed plans or pilot studies for potential clinical research projects.

Applications are accepted during the course of the year and are accepted on a rolling admission. Selected candidates will be invited for an interview. Fellowships are available on an annual basis.

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This page last updated on 07/25/2022

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