I have worked as a contracted clinical research associate (CRA) who runsning clinical trials to test Investigational Products for their effectiveness, risks and benefits to ensure they are safe to allow on to the pharmaceutical market. There are three major tasks in my work.:

Firstly, training CRA trainees is one of my tasks at work. There are many CRA trainees in my company. As I have worked in this industry for 4-5 years, I have taught them how to run the sites. Thus, I sometimes go to a clinical site with CRA trainees. I appreciate to havinge t ahe chance to train them because I canm relearning a lot from them by relearning about clinical trial procedures towhile training them.

Secondly, Ssetting up the clinical trial sites is another task at work. To start a clinical trial, a CRA sets up decided numbers of the clinical trial sites which pharmaceutical companyies have approved. The activities of setting up thea clinical trial include contract negotiation between a pharmaceutical company and the clinical site, preparing clinical trial documents to obtain an approval from an institutional review board and training the site staff to trial specific standard procedures.

Lastly, monitoring the trial site is an important task in my work. For monitoring the sites, a CRA visits the clinical sites on a regular basis, for example, once a month., Aas the sites are located in various areas in Japan such as Hokkaido, Fukuoka and Okinawa. A CRA frequently goes ton the business trip. On the monitoring visit, a CRA reviews the subject’s medical records and ensures if subjthectsy experienced any adverse event is after receiving investigational products. After the visit, a CRA makes a monitoring visit report to submit to a pharmaceutical company and Pharmaceutical and Medical Devices Agency.

In short, my main tasks at work are “training CRA trainees”, “Ssetting up the clinical trial sites”, and “monitoring the trial sites” which is an important task”.