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PI w/o previous clinical research experience...

By Mara Kryvicky posted 10-09-2012 01:38 PM

  
I am the senior clinical research coordinator that is starting clinical research at a medical clinic.  The PI is a board certified medical doctor in pain management, but does not have previous clinical research experience participating as a  PI on any studies as of yet.  I signed him up with a site management organization (SMO) last year which has over 25 years experience in managing research protocols.  I have helped him get a training certificate through NIH and reviewing of all GCP and ICH guidelines for the last year and he has participated as a sub-I for the SMO on a study.  A few companies were interested in conducting studies with us, however we were turned down because they said the PI has had no previous experience in clinical research as a PI.  Furthermore, although it does not matter, I have over 5 years of clinical trial experience.
Any recommendations on helping us to participate in a clinical trial would be greatly appreciated!
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William Hart
11-12-2012 12:49 PM

Hi Mara,
I too have been thinking about starting a clinical research facility in WV, where the clinical experience is very limited. For the research I have done, sponsors like the PI to have at least 5 years overall research experience, and of those 5 years, at least 2 years as PI. Of course, getting those 2 years is difficult. I have suggested to the doctors I've been in contact with to also get certified with ACRP as a certified PI. This will help, and to also look at Phase 4 studies. Most of these are studies approved drugs, and the sponsors are a little more lenient.