A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor,
a Trial Monitor or a Medical Monitor. The title will vary from organisation to organisation.
The job description will be the more or less same. A CRA is an individual employed
by a pharmaceutical or device manufacturer, by a contract research organization
(CRO) usually acting on a sponsor's behalf or by an academic institute conducting
clinical trials.
Regulations require that sponsors of clinical studies. Select individuals who are
qualified by training and experience to monitor their studies 21 CFR 31253 (d) ICH
Guidelines 5182 (b) also states that Monitors be appropriately trained and their
qualifications documented.
- Assure the protection of the rights, safety and well being of human study subjects
- To analyze and evaluate clinical data, to ensure investigator and site compliance
with the study drug protocol, overall clinical objectives, FDA regulations, ICH
Guidelines, Good Clinical Practice (GCP)
- Identify, help in the study site .Selection process, initiate, and eventually close
out clinical study sites
- To monitor the progress of clinical study sites participating in a clinical study,and
to assure the protocol is followed and data is reported accurately
- To make certain that the scientific integrity of the data collected is protected
and verified
- Assure that adverse events are correctly documented and reported
- Review all case report forms and compare them to source documents
This distance learning training program teaches you all the responsibilities of
the CRA.
This is the position who works for the Investigator / institution who handles most
of the administrative responsibilities of a clinical trial, is the liaison between
the clinical trial investigative site and the sponsor of the clinical trial, and
reviews all data and records before a CRAs visit. The title can be research nurse,
trial coordinator, study coordinator, research coordinator, or clinical coordinator.