FDA Patch Clamp Study of Drugs and Cardiac Ion Channels

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2022-0735
How to Apply

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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.

Application Deadline
3/31/2022 3:00:00 PM Eastern Time Zone
Description

*Applications will be reviewed on a rolling-basis.

A research opportunity is currently available in the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP)/ Division of Applied Regulatory Science (DARS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland. 

The research project will examine effects of drugs with defined clinical risk on several human cardiac ion channels using a whole cell patch clamp method and recombinant cell lines. These electrophysiology data will be integrated into a computer model of the human ventricular myocyte to predict the level of drug-induced proarrhythmia risk. 

Under the guidance of the mentor, the participant will learn about the systems approach taken by the DARS to determine drug safety and efficacy, and how translational research is designed to incorporate state-of-science information to yield solutions that immediately impact human health. The participant will also learn laboratory techniques, including electrophysiology, pharmacology, cell culture, and data analysis with the emphasis of reducing personal factors in experiments and enhancing intra-lab data reproducibility. 

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:

  • Non-employee nature of the ORISE appointment;
  • Prohibition on ORISE Fellows performing inherently governmental functions;
  • Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
  • The fact that research materials and laboratory notebooks are the property of the FDA;
  • ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications

The qualified candidate should have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

Preferred knowledge/ skills:

  • Knowledge in ion channel physiology / pharmacology
  • Skills in conducting / interpreting complex voltage clamp and current clamp experiments
  • Skills in using Igor Pro and writing macros, ability to prepare acutely isolated cardiomyocytes for patch clamp recordings, and/or knowledge in cell culture work
Point of Contact
Eligibility Requirements
  • Degree: Doctoral Degree received within the last 60 month(s).
  • Discipline(s):
    • Engineering (2 )
    • Life Health and Medical Sciences (46 )
    • Mathematics and Statistics (1 )
Affirmation

Have you lived in the United States for at least 36 out of the past 60 months? (36 months do not have to be consecutive.)

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