Parexel Interview Question

Have you been FDA Audited?

Interview Answers

Anonymous

Nov 3, 2020

Estimated Number of Site Visits: PSV: IMV: COV: SIV:

Anonymous

Mar 4, 2020

No, but I have a colleague that was audited. He shared his experience with me, he was transfer to COV when the last CRA was terminated. Before his visit, the study team advises him of an FDA Audit taking place soon. So he had to contact the SC to gather all the Subjects file, ISF, SDV, Monitor report(follow up report), and review any pending /closed queries. During the audit he was able to answer most of the questions and why was it done this way. He made the auditor aware that he recently took over this site due to last CRA was terminated. Good thing that only found minor things, he states he now understands why the last CRA was terminated because if it was him this would have never happened.

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