Discovering our professions: CRA (Clinical Research Associate)

Claire Lemaitre, Clinical Research Associate and Clinical Project Manager, presents the profession of CRA (Clinical Research Associate) and the impact of the sector development on the profession.

«The Clinical Research Associate monitors clinical studies at the research center level. At the beginning of the study, he will first select the participating centers, and then train them according to the study protocol.

Thereafter he will be the privileged contact of these centers and accompany them daily in the clinical study.

Within Soladis Clinical Studies, the Clinical Research Associate will be involved in quite different studies, both interventional and non-interventional, on drugs or medical devices, and on various therapeutic areas, and he will remotely follow studies and also alongside medical teams during his monitoring visits.

The sector is evolving considerably, particularly at the regulatory level, which involves constantly keeping up-to-date to be sure to apply good legislation and adapt our practice to it, in addition to adapting to the evolution of the sector. It should be known, for example, that nowadays the majority of data are collected with electronic case report forms (eCRF) at the expense of paper case report forms (CRF), enabling a remote and constant access to most data of the study.

So, thanks to these technical tools it is possible to have a closer and real daily monitoring of our clinical studies and have regular reports with research centers if we observe inconsistencies to correct directly with them.

Interventional studies require a much closer follow-up, it is therefore necessary to remotely monitor them more intensively than an observational study where we simply collect data contained in the patient’s medical file that does not require a sustained follow-up.

The objective of the Clinical Research Associate and the Clinical Team is to constantly adapt to the evolution of the study in order to make thoughtful actions in line with the needs of the sponsor, and which are appropriate to the legislation.»