The fact was that I didn’t have any extended knowledge about the duties and responsibilities of a CRA. Initially, I learned about the world of clinical trials during several post-graduate lessons and presentations in the University. For the first time, I learned for Phase I-IV, interventional and non-interventional studies, the importance and challenges of a pharmaceutical company to design and conduct a clinical trial. I thought, it was very interesting and I was excited about this upcoming opportunity. As a chemist researcher I had been assigned in the past, apart from other responsibilities, the synthesis and the development of new immunotherapeutic. Now, I needed to make a step further and learn how to work in a new, very competitive environment of Clinical Research.
From the very first days, I realized the large amount of information I had to assimilate, to get the full meaning of what is the role and the responsibilities of a CRA. The guidelines of Good Clinical Practice were the first handbook I read. It is the CRA’s gospel. I thoroughly studied it and I have learned that one of the primary principles is to protect the rights, safety and welfare of the human subjects. A principle which is presented, among other, on the Oaths of the physicians by the father of the modern Medicine, Hippocrates. Thus, it was clear that CRA’s role is more than just monitoring a clinical trial. It is not limited only to investigational sites assessment or source data verification. There is a higher value the CRA needs to serve and deliver. It is patient’s safety, his rights and the treatment of his illness.
The more I was studying the practices and regulations for conducting clinical trials, the more I felt that the role of the CRA is much more interesting and exciting than initially sounded, keeping me in a constant alert. I felt, it was an extraordinary pathway, entering the world of clinical research. Apart from all the above, it is a highly interactive role. As a start, a CRA must identify through the feasibility process whether the site is able to run the specific clinical protocol. Then the CRA must prepare and train the site and make sure that everything is ready. During the study the CRA must identify all details that can influence the outcome of the study. The CRA has to cooperate with the physicians and the study staff, on the details of the protocol and all applicable regulations. The CRA must motivate the study team to recruit patients and collaborate with the study staff verifying that the data captured in the CRFs are accurate and complete. And finally the time comes to close out the site. The CRA must check that all data is properly filed, every step has been recorded, validated, and all queries are resolved.
Although a CRA doesn’t get involved directly with the patients, he is ensuring that patients are well informed about the study drug and the consequences of the therapy by checking their Inform Consent. He ensures that the enrollment to the study is according to the inclusion-exclusion criteria and he manages the safety reports of any adverse events that might occur to the patients participating in the study, checking also duly submission of the report to the authorities by the physicians.
A CRA is a multi-role player. As a site manager he has to manage all site problems finding adequate solutions. As a Monitor he has to verify the data. As a liaison between the Principal Investigator and the Sponsor, he must communicate a lot with both parties. Finally, he must be fully committed to his mission. To be a successful CRA is a very complicated issue. You need to have a lot of skills but also to be open, well prepared, calm and a good listener, helpful, polite, assertive and honest, precise and proactive.
In this new pathway of clinical research, I am also expecting to face problems and obstacles. I am expecting a lot of challenges and worries. Deadlines, meetings, telephone calls and constant trips to the sites. But the emotion of helping the community, the patients and their families for a healthier life, is without doubt, the most important motive for me to continue working in the fascinating world of clinical research.
NEXT CRO, offers me the opportunity to be part of its clinical team and work for improving patients’ health and Quality of Life. We are facing challenges, but we stay committed and focused on improving the conduct of clinical trials. We wish to contribute to the improvement of patients’ perception of clinical studies by joining our forces with all stakeholders of clinical research. The biggest reward for me and for NEXT CRO, beyond our commitments, will be the patients’ relief and wellness.
That’s why WE THINK DIFFERENT, that’s why, WE want to DO IT DIFFERENT.
G.D.