The clinical research associate is a versatile and interesting career in the medical field. But what exactly is a clinical research associate and what do they do on a daily basis? This article will outline some of the responsibilities of a CRA and detail the daily life of a person in this rapidly expanding field.
The main function of a clinical research associate is to monitor and oversee clinical trials for new and existing medical products and drugs. They generally work with a sponsor company who has developed some type of medical product and wants to get it approved for sale to the general public. In order to sell this product in doctors offices and pharmacies it must be tested extensively and approved for use by the public. Many times clinical research associates work as independent contractors or freelancers. A clinical research associate ensures compliance with clinical trial protocol, and oversees the clinical trial process to ensure it complies with local regulations and general clinical practice. A CRA is usually required to have a degree in Life Sciences and often requires other testing and certifications.
To summarize, a clinical research associate sets up, monitors and completes clinical trials. They are a sort of project manager for medical trials.
But what exactly is a clinical trial and what does it comprise of?
A clinical trial is a type of scientific study that tests the effects, risks, and benefits of a medical product or medication. Several large trials are generally required before a product can be sold to a hospital or local pharmacy. Different types of trials are usually required and include but are not limited to: trials on healthy patients, trials on sick patients or patients with a specific condition, and followup trials after the launch of a new product to monitor side effects among the general public during mass use.
Some of the typical activities that a CRA may perform include:
* developing trial protocols
* presenting those trial protocols to a medical committee
* designing data collection forms (case record forms)
* coordinating with ethics committees
* managing regulatory authority applications and approvals
* locating and approving facilities for the trial
* working with doctors and consultants
* prepping the study centers for the trial
* training site staff to industry standards
* monitoring the trial throughout the entire duration
* writing visit reports and documenting the trial
* filing and logging trial documentation and reports
* accounting for unused trial supplies
* archiving study results and documents
* prepping final reports for publication
The job of a clinical research associate greatly varies from one trial to another so take this as a general overview rather than a detailed job specification. With certain companies, the CRA would be involved in the entire trial from start to finish. With others, a medical adviser initiates the trial, and the CRA would then be involved in collecting data and monitoring the trial after it is ready to begin.
To find all the latest clinical research associate jobs on the web, check out ClinicalResearchAssociate.org
Become a clinical research associate and start your new career today!