- CORPORATE TRAINING
- ABOUT AAPS
The Clinical Research Program is designed to develop the specialized knowledge and skills required to design, monitor and manage clinical trials. The program focuses on the global as well as Canadian health care system, health care legislation, procedures and practices of clinical studies. Using practical and current real world examples, AAPS integrated approach provides students with the foundation and knowledge to formulate a sound clinical development plan; ensure clinical trial data is credible and accurate; and that the rights, integrity and confidentiality of trial subjects are protected.
AAPS graduates from the Clinical Research program pursue careers in clinical research in Pharmaceutical, Biotechnological, Medical devices and Allied industries.
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 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 some 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, as supply is limited.
The CRA's responsibilities include but are not limited to the following: