So here we are, all five of us being part of different project teams and excited about performing our first visits as Clinical Research Associates (CRAs). Already a few months ago, we participated in SMS-oncology’s first CRA-academy. After a nerve-wrecking selection period, we – five young women with different backgrounds (including Biomedical Sciences, Pharmacy, Bio-science Engineering and Health Sciences) but all with a training or interest in oncology – were selected to take part in this internal CRA training program to become oncology specialized CRAs.
In an extensive training program, we received comprehensive theoretical trainings on oncology, ICH-GCP, drug development, study design, (EU) rules & regulations, CRA tasks & responsibilities and hundreds of abbreviations. A part of the lectures was given by Ad van Dooren, Emeritus Professor of Pharmaceutical Sciences at the University of Applied Sciences in Utrecht. Another part was given by the senior staff of SMS-oncology.
The CRA-academy not only served as a jumpstart to our career as recent graduates, but was also an instructive, interactive and fun way to get to know SMS-oncology as a company. Employees from SMS-oncology were closely involved in the CRA-academy of which many provided hands-on training and workshops covering a wide range of topics, such as: regulatory submissions, communication and planning, data management, pharmacovigilance, tumor evaluation, RECIST 1.1 and oncology monitoring. In addition, we received several trainings on different tumor indications from physicians in the Medical Affairs department.
But before we could join the SMS-oncology team, we needed to pass an exam comprising of two parts: part 1 being a multiple choice exam on ICH-GCP, and part 2 consisting of open questions on case studies, dilemmas and tasks. And, most important; we would like to notify we all passed! This was celebrated and rewarded with the desirable certificate stating we had successfully completed the CRA-academy. From this moment we could finally bring our knowledge into practice, and at that point we were more than ready to experience the “real deal” and start with visiting sites accompanied by SMS-oncology’s senior CRAs.
In the meantime, each of us have been assigned to one or two clinical projects and the first accompanied site visits have been performed in the Netherlands, Belgium and Germany. Looking back at the CRA-academy and certainly looking forward, we’re proud to have seized the opportunity to become oncology CRAs, and committed to further develop ourselves in our goal of contributing to the development of new drugs for cancer.
Alicia, Cleo, Eveline, Mariska and Fleur