| is a clinical research associate and what do they do? | | | | a medical or pharmacutical company millions of dollars, |
| The main function of a clinical research associate is to | | | | and is the main function of a CRA. |
| monitor clinical trials. They work directly with a | | | | Typical work activities for a clinical research associate |
| sponsor company of a clinical trial, as an independent | | | | include: |
| contractor or freelancer. Many times they are | | | | * developing and writing trial protocols |
| employed by a CRA company who contracts their | | | | * presenting trial protocols to a committee |
| employees out to medical manufacturers. This is | | | | * designing data collection forms, known as case |
| similar to a consultant company. Other CRA's work as | | | | record forms |
| freelancers on a case by case basis. A clinical | | | | * coordinating with the ethics committee |
| research associate generally ensures compliance with | | | | * managing regulatory authority applications and |
| the clinical trial protocol, and oversees the clinical trial | | | | approvals |
| as a whole. A clinical research associate is usually | | | | * locating and assessing the suitability of facilities at a |
| required to have a degree in Life Sciences and needs | | | | study center |
| good knowledge of clinical practice and local | | | | * liaising with doctors and consultants on conducting |
| regulation. There are also custom courses and exams | | | | the trial |
| that can be taken for additional certification. | | | | * setting up the study centers |
| To put it simply, a clinical research associate (CRA) | | | | * training the site staff to industry standards |
| sets up, monitors and completes clinical trials. Without | | | | * monitoring the trial throughout its duration |
| clinical trials, drugs and medical products can not be | | | | * writing visit reports |
| approved for sale through doctors or pharmacies. It | | | | * filing and collating trial documentation and reports |
| is a very important step in the release of new | | | | * ensuring all unused trial supplies are accounted for |
| medications. | | | | * archiving study documentation |
| A clinical trial is a scientific study of the effects, risks, | | | | * preparing final reports for publication. |
| efficacy and benefits of a medical product or drug. | | | | The job of a clinical research associate varies quite a |
| Trials have to be carried out before a product can be | | | | bit so this is just a general overview. With some |
| sold to a hospital or local pharmacy. Different types | | | | companies, the clinical research associate would be |
| of trials include: trials on healthy patients, trials on | | | | involved in the entire process from start to finish. In |
| patients with a disease, and followup studies | | | | others, a medical adviser would initiate the trial, and |
| conducted after the launch of a new product to | | | | the clinical research associate would be involved in |
| monitor side effects and safety issues in large | | | | collecting data after the trial had been set up. In |
| groups. The goal of a clinical trial is to expose side | | | | either case, the job of a CRA focuses on watching |
| effects and safety problems in advance, but as you | | | | over clinical trials to ensure that medical products and |
| may have seen, medications often get recalled later | | | | medications are safe for public use. It's a rewarding |
| on. This is why products need continuous clinical trials | | | | career with huge potential in a quickly growing |
| in different sized groups. Once exposed to the | | | | industry. |
| general public, other issues often arise. This can cost | | | | |