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The Clinical Research Associate (CRA)
or Monitor is a professional, who monitors the conduct of clinical trials on
behalf of a Sponsor, a manufacturing company, that does drugs/medical devices research.
The CRA ensures compliance with the Trial Protocol, visits
regularly the sites, checks the clinical site activities, reviews the Case Report Forms (CRFs) and communicates
with the clinical research nurses and the clinical investigators.
The CRA plays a fundamental role in
ensuring the success of a trial as he is typically the first one to
identify any data discrepancies and regulatory issues at a clinical trial
site.
Usually CRAs must possess an
academic degree in Life Sciences and need to have a good knowledge of
the Good Clinical Practices (GCP) and the FDA Title 21 of CFR (Code of
Federal Regulations)
They have to make sure that the safety of the
study participants is not jeopardized, they assess the sites'
compliance with the Study Protocol and the Code of Federal
Regulations (CFR);
They evaluate clinical site facilities to assess
their ability to conduct a clinical trial; they address all study-related
questions with the site staff and write reports to document the findings on the conduct
of the trial at a given clinical facility; they review
regulatory documents but don't handle patients, nor interpret study results.
This large array of responsibilities, requiring high qualification, as well as the continuously growing
demand for new CRAs, explains the high level of the salaries in this
rewarding career.
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Professions in CR
