As a Clinical Research Associate (CRA) you are responsible for setting up, coordinating and supervising clinical studies (trials) with medicines, medical nutrition or medical devices. You will carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centers. During a monitor visit you will verify various (patient) data included in the eCRF (electronic Case Report Form) by the physician-researcher (investigator, medical specialist) or research nurse. This process, called source data verification (source being the electronic patient file, EPD) checks whether the study has been carried out in accordance with applicable laws and regulations (Good Clinical Practice, ICH-GCP) and company Standard Operating Procedures (SOP’s). You will also check whether the rights of the healthy subjects and / or patients participating in the study are being respected, i.e with respect to ethical and privacy aspects. Furthermore, you will not only be responsible for monitoring the study, but also for logistics and coordination of the study. You will be the spider in the web, being the primary contact with many different parties such as doctors / researchers, research staff (e.g. nurses), central or local laboratories, pharmacists, ethics committees and others, in particular also responsible parties at the sponsor / client (the pharmaceutical company). The objective of a clinical drug study is to demonstrate that the investigational product has a certain desired effect for the disease or disorder for which it is being developed, whether it is safe, and that all adverse reactions / adverse events have been reported according to the study protocol and have been rated on seriousness, severity, and causality with the investigational product. Clinical studies are classified according to their phase in development:
- Phase I – In this phase the active substance is to be tested on a small group of healthy subjects. The central question then is whether the substance is safe and with which dose development is to be continued;
- Phase II – In this phase the effect of the drug (or investigational product) on patients (who have the disease or disorder for which the medicine is being developed) is investigated. Is it effective and safe in the desired dose? The number of patients in this phase is usually a few tens to some hundreds;
- Phase III – In this phase, the research product is tested on (future indication) patients, usually in comparison to placebo, often on top of usual care. The objective is to gain more insight into the effectiveness (efficacy) and side effects (safety). The number of patients in this phase is a few hundred to thousands. With larger numbers you can measure and test more accurately, with less biass and better clinical significance. Sometimes side effects come up that did not come up before;
- Phase IV – This phase of development takes place after the registration of the investigational product. The purpose of studies in this phase is to investigate the use of the research product in daily practice and to obtain additional safety information, insight into the cost-effectiveness (efficiency), often in connection with access to the market, or reimbursement by insurers. Also, in this phase the drug is often compared with competing drugs, or it is checked whether the drug is suitable for other indications than those for which registered in first instance.
The CRA position is a diverse and dynamic one. Often travelling back and forth from research centers (clinical trial sites) and spending full days on source verification and meetings with investigational hospital staff, the next day you work in the office or from home writing visit reports. You usually work on multiple clinical trial projects. As a CRA you can develop within the hierarchy of the clinical research department, or make a switch to, for example, the medical department into positions like Medical Science Liaison (MSL) or Medical Adviser.
Your background and profile:
- Completed Bachelor, Master or PhD in life science;
- Excellent computer skills;
- Excellent communication and organizational skills;
- Flexible, accurate and high level of integrity;
- Knowledge of GCP, completed Good Clinical Practice training is an advantage (and conditional on the job itself);
- Drivers license.
Terms of employment and salary
The starting salary of a Clinical Research Associate is between € 2.800,- and € 3.500,- per month. Secondary employment conditions typically entail a lease car.
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