What is a clinical research associate and what do they do?

The main function of a clinical research associate is to monitor clinical trials. They work directly with a sponsor company of a clinical trial, as an independent contractor or freelancer. Many times they are employed by a CRA company who contracts their employees out to medical manufacturers. This is similar to a consultant company. Other CRA’s work as freelancers on a case by case basis. A clinical research associate generally ensures compliance with the clinical trial protocol, and oversees the clinical trial as a whole. A clinical research associate is usually required to have a degree in Life Sciences and needs good knowledge of clinical practice and local regulation. There are also custom courses and exams that can be taken for additional certification.

To put it simply, a clinical research associate (CRA) sets up, monitors and completes clinical trials. Without clinical trials, drugs and medical products can not be approved for sale through doctors or pharmacies. It is a very important step in the release of new medications.

A clinical trial is a scientific study of the effects, risks, efficacy and benefits of a medical product or drug. Trials have to be carried out before a product can be sold to a hospital or local pharmacy. Different types of trials include: trials on healthy patients, trials on patients with a disease, and followup studies conducted after the launch of a new product to monitor side effects and safety issues in large groups. The goal of a clinical trial is to expose side effects and safety problems in advance, but as you may have seen, medications often get recalled later on. This is why products need continuous clinical trials in different sized groups. Once exposed to the general public, other issues often arise. This can cost a medical or pharmacutical company millions of dollars, and is the main function of a CRA.

Typical work activities for a clinical research associate include:

* developing and writing trial protocols
* presenting trial protocols to a committee
* designing data collection forms, known as case record forms
* coordinating with the ethics committee
* managing regulatory authority applications and approvals
* locating and assessing the suitability of facilities at a study center
* liaising with doctors and consultants on conducting the trial
* setting up the study centers
* training the site staff to industry standards
* monitoring the trial throughout its duration
* writing visit reports
* filing and collating trial documentation and reports
* ensuring all unused trial supplies are accounted for
* archiving study documentation
* preparing final reports for publication.

The job of a clinical research associate varies quite a bit so this is just a general overview. With some companies, the clinical research associate would be involved in the entire process from start to finish. In others, a medical adviser would initiate the trial, and the clinical research associate would be involved in collecting data after the trial had been set up. In either case, the job of a CRA focuses on watching over clinical trials to ensure that medical products and medications are safe for public use. It’s a rewarding career with huge potential in a quickly growing industry.

Author Bio: To learn more about the clinical research associate as a profession and to find all the latest clinical research associate jobs from across the web, check out ClinicalResearchAssociate.org

Category: Medical Business
Keywords: clinical research associate