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Clinical Research Associate Training | Jobs In Pune The way medical
research is being done and the need to develop new drugs are changing
like never before. Working as a Clinical Research Associate (CRA) is a
very exciting and stimulating job. This site is to enhance your knowledge
regarding CRA trainings forwarded by CRB Tech .
There is no such thing as a standard day in the
role a CRA because being a significant part of an
organization every days sees a new challenge.
A Clinical Research Associate (CRA) is a health-care professional and very
knowledge-intensive. The
experts find
their
place
in
various organizations related to pharmaceuticalsand medicine, in both
private and government sectors.
A clinical research associate (CRA) runs clinical trials to test drugs for
their effectiveness, risks and benefits to ensure they are safe to allow on
to the market. They may work on new as well as existing drugs and are
usually employed by either a pharmaceutical company or a contract
research organization (CRO) which works on behalf of pharmaceutical
companies.
The CRA will typically be involved in all stages of the clinical trial,
including identifying an investigation site and setting up, initiating,
monitoring and closing down the trial.
Clinical trials may be carried out at various stages or phases and include
trials on healthy humans, trials on patients with a disease, and studies
conducted after the launch of a new drug to monitor safety and side
effects.
The responsibilities are assigned by the employer as per organization
policies; but typically includes:
develop and write trial protocols and present trial protocols to a steering
committee
design data collection forms, known as case report forms (CRFs)
coordinate with the ethics committee
identify and assess the suitability of facilities to be used as the clinical
trial site and a proficient investigator
set up the trial sites and monitor the trial throughout its duration
verify that data entered on to the CRFs is consistent with patient clinical
notes, known as source data/document verification (SDV);
collect completed CRFs from hospitals and general practices
close down trial sites on completion of the trial
discuss results with a medical statistician, who writes technical trial
reports
archive study documentation and correspondence
prepare final reports and occasionally manuscripts for publication
In simple words, a Clinical Research Associate is the soul of the
organization.
To become a clinical research associate (CRA) you need to have either a
degree or postgraduate qualification in nursing, life sciences or medical
sciences.
excellent communication skills (both written and oral) and the ability to
schedule