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Clinical Research Program is basically a scientific study of the effects, risks, benefits and efficiency of a medicinal product. This branch of medical science determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens that are proposed for human use. All these things are carried out prior to the release of the medicine in the market. These trials come with a lot of stages and studies. After completing the clinical research program, an individual can become Clinical Research Associate (CRA). The work of CRA is to monitor the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on the behalf of a sponsor. We can also call CRA as clinical research monitor, executive, scientist or coordinator that depends on the company.
Responsibility of the Work
As an Investigator, an individual handles many administrative responsibilities of a clinical trial. He works as a mediator between the clinical trial investigative site and the sponsor of the clinical trial and he reviews all data and records before the visit of Clinical Research Associate (CRA). The key role of Clinical research associate is to design, implementation and monitoring of clinical trials. He is also responsible to plan and implement all the activities required to conduct and monitor complex clinical trials. He ensures that good clinical practices are followed.
Minimum Qualifications
For entering in the Clinical Research Field, one should have a B.Sc. degree. Mainly, an individual should be a science graduate from pharmacy, medicine, life science and bioscience. Bioscience includes various fields such botany, zoology, biochemistry and genetics. For pursuing Clinical Research Program, it doesn’t matter what your age is.
To sum up, we can say that Clinical Research Program is an organized way to study for the new drugs in human subjects that generates data to discover and verify the clinical, pharmacological or adverse effects for the determination of safety and efficacy of the new drug. |
