Have you ever been part of a clinical investigation led by the FDA due to non-compliance? How familiar are you with GCP standards and practices?

"Fortunately, I was never involved in such a clinical investigation as I, and the professionals I have worked with are highly knowledgeable regarding GCP standards and practices. I pride myself on being highly ethical and would not hesitate to reach out to a superior should I have doubts about the required standards and practices."

The interviewer would like to know how closely you follow Good Clinical Practice (GCP) and the extent of your knowledge on the subject. Good Clinical Practice (GCP) is a uniform standard enforced by the FDA. It must be followed by all clinical trials involving human participants. Because every clinic will have their internal procedures, in addition to the GCP standards, the interviewer would like to know more about the extent of your knowledge when it comes to good clinical practice.

"The company I currently work for has an incredibly high standard when it comes to good clinical practice. Fortunately, I have never worked for an employer that has been in non-compliance with FDA standards. In my current position, I train new researchers on our GCP standards so I would rate my knowledge as expert level."