Clinical research is a fascinating field. Things are moving at a dizzying pace and there is no such thing as routine. Annie Raymond Desgagné has worked in it since 2005. She started out as a junior clinical scientist, then became a Clinical Research Associate (CRA). Even today she feels she is actively involved in advancing medical knowledge and improving the quality of life of patients. She presents us here the reality of being a CRA.
What does the work of a clinical research associate consist of?
The work of a clinical research associate consists of ensuring that the data used in clinical studies are reliable and unbiased. To do this, most of his time is spent reviewing the study participants’ files to verify and compare the data.
Specifically, the clinical research associate contributes to recruiting and selecting the sites participating in the study. During the study he ensures that the protocol is followed to the letter and that the regulator’s documents are valid and always accessible. Sometimes the CRA counts the medication used in the study and ensures it is kept under the conditions described in the protocol. Finally, the CRA verifies, at the end of the study and for each site, that the source documents containing the study data and regulatory documents are completed and archived, and there is no more study medication remaining at the site.
In addition to these tasks, the clinical research associate has to arrange his schedule to visit the study sites at the frequency indicated in the protocol. Since these sites can be in different countries, the work of the clinical research associate requires a lot of travel. Travelling can take up 80% of their time. You had better like planes, trains and cars!
What skills are sought for a position as a clinical research associate?
The work of a clinical research associate requires being open to change (which is continual) and being very organized. There also needs to be close attention to details, being able to maintain good interpersonal relations and being honest.
What studies are required to work in clinical research?
At least a bachelor’s degree in the health field (pharmacy, biology, nursing, biomedical sciences, etc.) is essential. Some universities, such as the Université de Montréal, offer specialized courses in the pharmaceutical sector which are recognized by industry even if they don’t guarantee employment. In general, companies require at least two years of experience in clinical research to become a CRA. Fluency in English is also required.
Some opportunities in clinical research
- Specialists in regulatory documents;
- Specialists for liaison with government regulatory bodies (e.g., Health Canada, the Food and Drug Administration, the European Medicine Evaluation Agency, etc.);
- Contract managers with the study sites;
- Study Managers;