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clinical research

Career as Clinical Research Associate

Published On: 22 Jan 2010 | Last Updated On: 04 Jul 2012

A Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.


Clinical research a challenging field:

With the rising cost and competition in various fields of vocational training, Clinical research could be a field with lot of challenge for life-sciences, dental and medical graduates. For many of the science graduates aspiring for growth, research is a boon because science and research are inseparable. When research offers an attractive salary too, guardians and parents are obviously drawn towards the field. Although many aspire to achieve success some could not achieve what they aspired for. How can the course equally fulfill the aspirations of medical and non medical graduates? These are some queries which have to be answered so that students genuinely interested in challenging but emerging areas are not misled. It is necessary to clear some of the myths and put forth the facts of careers in clinical research. If put together Clinical research is a multi-disciplinary effort. Clinical research is applied research. In simple terms, it involves testing of new medication in human population. The purpose is to evaluate whether the medication is safe and effective when it is used for the disease under question.

Behind the curtain

Research would have started at least four to five years before the drug was tested on humans in the research and development centers of the sponsor. The diseases that are unaddressed or are yet to find a good medication with fewer side effects are first identified. Research is then carried out to understand the molecular targets that need to be rectified by drugs. With this information, drug discoverers synthesize chemicals and identify the suitable candidate molecule through sophisticated technologies like high through put screening. The probable candidate is then put for further pharmacological and toxicological testing in experimental animals. The molecule is then subjected to clinical trials. The cost of drug development is approximately $1.2 billion and it takes about eight to 12 years for the drug to reach the market from the time it is discovered.

The Clinical Research team

At the Sponsor/Contract (Clinical) Research organizations (clinical research organizations are independent private companies to whom the sponsor sometimes outsources the clinical trial projects): Clinical Research Associate, Clinical Trial Administrator, Project Manager, Medical Writer, Quality Assurance Manager/ Executive, Medical Advisor (These positions are exclusively for medical professionals, the rest are available for any life-science graduate/post graduates), Medical Monitor, Data Entry Operator, Data Manager, Data Validator, Bio-statistician, Manager- Regulatory Affairs.

Companies into clinical research Sponsor companies:

Johnson & Johnson, Biocon, GlaxoSmithKline Beecham, Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas Piramal, Dr.Reddys Laboratories, Novo Nordisk, Pfizer etc.

CROs: Quintiles, Manipal Acunova, ICON International, Clintec, Clinigene International, Accenture, Paraxel, Asian Clinical trials, Paragon, etc.

 


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