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  • Mattie718 replied to the topic Discussion Topic: Having a "clinical background" in the forum Clinical Research Basics 6 years, 11 months ago

    I think it is very situational as to the qualifications for each position involved in the clinical. The investigator is someone who should probably have a clinical background, but may pass if they have certain other qualities. Since they will usually have a team of clinical associates performing most of the procedures, I think the Investigator should have some sort of Project Management experience. They need to know how to delegate tasks, follow a timeline and budget, and be able to manage all of the team members effectively. Part of this management also includes ensuring every single form and document is filled out completely to cover all aspects of performing the experiment. Their duties are not necessarily driven by needing to understand entirely the medical part of the trial. I think the Clinical Research Associate is the person who is most likely to have experience as a nurse or clinical assistant. This is because they need to fully understand the procedures being conducted and be able to interact with patients and have those interpersonal skills. The only exception I think would be a Biomedical Engineering graduate with a master’s degree and lots of experience doing research in a lab, preferably having completed a thesis project as well. The data analyst is probably the position that requires the least amount of clinical expertise. Once all of the data and results have been collected, they pretty much just become numbers at that point. I think the person best suited for this would be a Biomedical Engineering graduate with a background in various simulation/analysis software and statistical knowledge in order to dissect the results and display it in the most useful way so as to draw a conclusion.