Monthly Archives: June 2013

Best Practices Series: Know What WE Know About CRA Training

What should you look for in a Great CRA? 

As anyone in the industry understands, a CRA has an integral role to play in the proper execution of a successful study.  All CROs look for competent, qualified professionals when hiring their CRAs and there are certain professional characteristics they look for when doing so.  Read on to discover the best practices and qualifications that CROs look for in a new CRA.

CRA's are the backbone of a clinical trial

CRA’s are the backbone of a clinical trial

Qualifications and Experience
While it’s true that everybody has to start somewhere, when looking for to hire a CRA, CROs are very concerned about clinical experience and the type of qualifications a CRA has.  There is no law that requires a specific certification for CRA training but a candidate that has successfully completed a CRA certification program has proven their dedication to the industry.  Furthermore, a great CRA has industry experience of some kind.  A CRA should have at least a Bachelor’s degree in a scientific or medical field of study and preferably experience working in some aspect of the industry (such as a nurse or a lab technician).

Protocol Training
An in depth understanding of proper protocol is an absolute must-have for any new hire.  As Dr. Summit, of Clinical Research Academy of America says, “If you don’t know GCP regulations, that is ok; make sure you know the Protocol!”  Protocol regulations are what protect clients, participants and the integrity of the study.  If proper protocol is not followed and the CRA is unable to recognize that, the validity of the study is in jeopardy.  This translates into the loss of time, energy and money on the part of every entity invested in the study.   A properly qualified CRA will be able to demonstrate best practices in protocol recognition and error correction.

Thorough Understanding of GCP
Good Clinical Practice (GCP) regulations are another field of knowledge that the best CRAs know well.  A skilled CRA is able to note errors in GCP and suggest corrections before they invalidate a study.  This is vitally important and one of the primary responsibilities of a CRA.  A new hire must be able to satisfy an interviewer that he or she has a working knowledge of GCP and is comfortable monitoring a study-site for appropriate procedure within that framework.

Attention to Detail
A genuine understanding of procedural protocols and GCP, as well as clinical experience and a solid background in the industry are all necessary components to performing as a CRA.  Yet knowledge alone is not what makes a CRA great.  Interviewers look for characteristics that denote a personality that will shine as a CRA.  A prospective hire must give the interviewer a sense that they have complete attention to detail and are comfortable taking the time necessary, even under pressure, to be thorough and exacting.

A CRA that can demonstrate best practices in the industry is an invaluable support person for a smoothly running research machine. 

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(Although some source material was found on the CCRA (Clinical Research Academy of America) website, it does not imply an endorsement or recommendation of the curriculum)