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What Does a Clinical Trial Investigator Do? |
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Clinical trials are an investigation using human subjects intended to uncover or ensure the clinical and pharmacological effects of a product to determine safety and efficacy. A clinical trial investigator is usually a physician in private practice who participates in these studies. This work may help to develop drugs and medical devices, determine effective treatments for various diseases, and provide patients alternative treatments. A doctor does not need to have an association with a teaching hospital or medical school to be an investigator. He also does not need to have prior experience as a clinical trial investigator to qualify. The most important factor the physician needs to determine when considering if he is a good fit for the role is a thorough understanding of the commitment needed to conduct a clinical trial. When a physician considers the possibility of participating in a clinical trial, he might want to consider if the trial will fit into his patient population. He should also consider if he or she has the equipment required to conduct the trial. Adequate staff to perform all of the clinical trial investigator duties is another requirement. There are four main components of the clinical trial investigator team: the research subject, the principal investigator, the sub-investigator and the clinical research coordinator. The research subject is the person participating in the clinical trial. He or she may be healthy or infected with a disease or afflicted with a specific condition for the purposes of the trial. In order to act as the principal clinical trial investigator, a physician is should have training and experience in the area in which the trial is being performed. The principal investigator oversees all aspects of the clinical trial. This includes, but is not limited to, the evaluation and treatment of research subjects, ensuring correct adverse event reporting, and designing a procedure for proper retention of documents. Sub-investigators assist the primary clinical trial investigator. These roles are typically filled by either nurse practitioners and/or physician’s assistants. The clinical research coordinator runs all aspects of the day-to-day itinerary of the trial. Among the myriad duties performed by this pivotal role is the determination of the study’s protocol assessment and feasibility. The decision to become a clinical trial investigator can provide a medical professional with an opportunity to play an integral role in the advancement of medicine. This can provide great professional satisfaction. Many investigators experience other career benefits, like recognition and professional development.
Written by
Kevin P. Hanson |
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