Fundamentals of Clinical Research, an interactive program providing classroom training for the clinical research professional, begins with the history of legislation and regulations that govern clinical research and an overview of drug, biologic, and device development. Course participants develop a thorough knowledge base of Good Clinical Practices and International Conference of Harmonization guidelines (E6, E2A), gaining a solid understanding of clinical trial development and management.
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 :
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. 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.