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  • hruship101 replied to the topic Discussion Topic: Having a "clinical background" in the forum Clinical Research Basics 7 years, 5 months ago

    This is an interesting question! I agree with most of the participants that having clinical background is a plus, but again it depends on the type of role within the CRA profession. For example, Statistician might not need as much medical background as Principal Investigator because they are mostly working with the data and analysis. Principal Investigator is primary contact and provides specific information regarding complying to FDA regulations with the clinical trials. There are many documentation, critical deadlines and regulations that the industry professional like nurses and doctors have practiced and it is critical for them to know the clinical background information. However, depending on the individual’s role it may be an advantageous if everyone involved in the clinical trial is aware of at least the risk involved.