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 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.
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 organization, academic institution, or site management organization. A CRA can work either in-house or in the field, requiring 50-70% travel. A field monitor will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.
Pharmaceutical companies are presently seeking to reduce the development time necessary for their products to receive FDA approval for marketing. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. Inadequate monitoring can jeopardize 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 the supply is limited.