A
Clinical Research Associate, also known as a Monitor,
is an individual that oversees the progress and conduct
of a clinical trial. A clinical trial is usually implemented
by doctors at a hospital, clinic, or doctor's surgery.
The CRA is required to oversee the initiation, progress
and conduct of the clinical trial to ensure the scientific
integrity of the data collected and the protection
of the rights, safety and well-being of human study
subjects.
The CRA’s responsibilities include, but are not limited to, the following:
Performing study drug accountability;
Verifying the documentation of the informed consent process for each study subject;
Ensuring that non-serious and serious adverse experiences are properly documented
and reported;
Reviewing the case report form against the subject's medical record for completeness
and accuracy;
Ensuring the filing and maintenance of the required regulatory documents.
The CRA frequently has a health care or science background (e.g. nurse, medical
technologist, or physical therapist; or Bachelor's, Masters, or a Ph.D. in a
science). The CRA is usually employed by a pharmaceutical company, contract research
organisation, academic institution, or site management organisation. A CRA can
work either in-house or in the field, requiring 50-70% travel. A field monitor
will visit multiple sites and interact with the study co-ordinator and the investigator
conducting the trial.
Pharmaceutical companies are presently seeking to
reduce the development time necessary for their products
to receive approval for marketing.
Monitoring of
a clinical trial is the first mechanism in identifying potential data discrepancies
and regulatory issues. Inadequate monitoring can jeopardise the safety of the
study participant and/or is a leading contributor to the delay in gaining drug
approval. A well-trained and knowledgeable CRA plays a vital role in protecting
the study participant and helping to reduce the time between drug development
and marketing approval. The demand for knowledgeable and trained CRAs continues
to grow, however supply is limited.
