A
Clinical Research Associate (CRA) is an individual
that oversees the progress and conduct of a clinical
trial. He or she may work directly with the sponsor
company of a clinical trial, as an independent
freelancer or for a Contract Research Organization (CRO).
A clinical trial is usually implemented by
physicians at a hospital, clinic, or physician's
office. 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:
Monitoring that
the physician adheres to Good Clinical Practices
and the study protocol.
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;
Clinical
research is a rapidly expanding field, creating exciting
opportunities for trained professionals. Graduates of this
program are employed in both the hospital sector and
research industries, and can advance to management roles.
Salaries may range from £23,000 to £50,000 a year. CRAs work
in a broad range of research settings, including:
Academic
health centers
Government agencies and departments
Contract
research organizations
Private
companies, such as pharmaceutical, biotechnology, and
medical device firms
