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Who is a Medical Monitor and How to Become One?

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Who is a Medical Monitor and How to Become One?

Medical monitoring plays a crucial role in the clinical trial review process.
If you are a medical professional and want to contribute to pharmaceutical research and development, then one of the most common option available to you is to work as a principal investigator in a hospital or a private clinic set-up and enroll and manage patients in clinical studies sponsored by drug companies. This, however, may not be your cup of tea as you may not be an actively practicing doctor or your interests may not lie in this type of work. If that is the case, you could possibly explore opportunities to work directly with the pharmaceutical or contract research companies and assist them in designing clinical trial protocols, build case reports, or take control of clinical research projects and provide specialized medical input for medical related issues encountered during clinical trials. A profile such as this will allow you to be involved in the treatment of volunteers participating in the studies while at the same time not being the one delivering the treatment. A particular industry position is available that encompasses the roles we mentioned above. This position is that of a medical monitor (MM).

What exactly is the need for medical monitors?

Clinical research associates (CRA’s) and study coordinators are not necessarily medically qualified, and the investigators who do, may not have all the answers related to the product that they are testing. Further, they usually fail to see or do not care, about the “big picture” in which the clinical trial and the product development fits. This is particularly true in late phase studies, in which several clinical trial sites around the nation collectively contribute to each clinical study. Thus, the medical monitors role can be thought of as lead doctor for a large-scale research study.
A key role of the medical monitor is to respond to questions from investigators, study coordinators, and research associates, regulatory personnel, and other staff. Due to their medical and study-specific know-how, medical monitors are in a distinctive position to offer clinical trial-related training to the study site staff (such as, guidance on how to carry out required examinations or how to most effectively increase a study subject’s dosing). Additionally, because the medical monitor is aware of what is occurring at every single study site participating in the clinical trial, they are able to deliver across-the-board support and guidance that helps maintain consistency across the clinical trial.
This described job profile may seem somewhat unclear. The following cases are common ways in which medical monitors guide clinical trials and should help you understand better.
Case 1:
Unknowingly, the principal investigator at a clinical trial site enrolls a subject who does not fit the inclusion/exclusion criteria specified in the study protocol. The principal investigator is now not sure what to do.
In such a case the medical monitor is contacted to figure out whether the subject must right away be removed from the trial, and if so, what procedures (e.g., blood tests or physical examination) need to be carried out.
Case 2:
Numerous clinical trial sites participating in the study report to the medical monitor a substantial increase in blood pressure for various subjects enrolled in the clinical trial. Due to the fact the medical monitor realizes that this is not a one-off case, he or she can seek advice from other physicians at the pharmaceutical company to figure out what measures should be adopted for all sites: They can suggest to carefully observe blood pressures, stop the study drug if the subject’s blood pressure increases considerably, or administer blood-pressure-lowering drugs as required. The medical monitor can further propose that the study protocol be amended to exclude patients with a history of high blood pressure.

How to Become a Medical Monitor?

To become a medical monitor, you must strongly consider getting specialized training related to clinical trials and the pharmaceutical industry. At the James Lind Institute we offer multiple online programs that will help you to become a medical monitor. You may consider our Advanced Postgraduate Diploma in Pharmaceutical Medicine. This program covers all important aspects of the job profile of a Medical Monitor and is highly accepted in the industry.
To know more about this internationally accredited online program visit the following link: Medical Monitor Training.
Good luck!
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