Biomedical Research

The Clinical Research Associate (CRA), also called the monitor, is the principal communication link between the sponsor and the investigator.

A CRA sets up, monitors and completes clinical trials. The CRA plays a pivotal role as he/she oversees the initiation, progress 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.

A CRA has an extensive set of roles and responsibilities in a clinical study include ensuring the well being and safety of the subjects, coordinating with the ethics committees, ensuring the authenticity of the data entered into the CRF, ensure GCP guidelines are followed, make sure the investigational drugs are accounted for, all the adverse events are reported and ensure that all regulatory documents are properly filled.

The ideal requirement for a clinical research associate is to possess an academic degree in life sciences along with a good knowledge of GCP, processes in drug development and local regulations. The CRAs are generally employed by pharmaceutical companies, contract research organizations, academic institutions, or site management organizations.

In the current industry settings, there exists a mismatch between the demand and supply of knowledgeable and trained CRAs.

Training:

Persons who aspire to be CRAs should take up CRA specific training in order to know the nitty gritties of the roles of a CRA in the clinical trial process. The candidates should make sure that they will learn practical, decision making and interpersonal skills in the process.

The training should ensure that you will have the knowledge of the following before you take up the responsibilities of a CRA:

o Good knowledge of the drug development process
o Knowledge of the GCP guidelines
o Ethical and regulatory guidelines of the country
o Good interpersonal skills
o Good communication skills