Clinical trial coordinator
Other denominations
Principal investigator
Description
The Law on Medicinal Products defines clinical trials as "all experimental evaluation of a substance or drug through its administration or application to human beings". The process for the approval of a new medication for human use is complex and time consuming. After pre-clinical investigation (in vitro and in animals), a new drug is tested on humans during clinical trials (phase II, phase III and phase IV, depending on the type of population and number of patients included). The whole process usually involves at least 3,000 people, lasts between five and ten years, and can have a total cost of between 300 and 500 million euros. Registration requires presenting all the scientific documentation of consecutive protocols and the results obtained.
The clinical trial coordinator is the person responsible for the clinical trials of a (bio) pharmaceutical company or CRO (Contract Research Organization). In general, this professional directs a team of several specialists in different fields (assistants, clinical trial monitors, biostatisticians and computer engineers). This requires close collaboration with authorities, physicians/specialists or opinion leaders, and internal R&D departments.
Tasks
- Define the strategy for clinical research in close collaboration with the medical management and in accordance with the company's strategic priorities.
- Take charge of the strategy, approach and development of clinical activities for the approval of a novel drug.
- Establish the strategy and direct the clinical plan for each product.
- Define relationships with CROs, supervise clinical trial protocols, identify principal investigators and participate in working groups.
- Determine the operational and material requirements of studies.
- Determine the budgets and financing mechanisms required by studies.
- Work according to stipulated regulations (EMA, FDA) for each type of product and disease.
- Work under the standards of Good Clinical Practice (GCP) and the company's corporate responsibility.
- Ensure that patients participating in the study are informed about new drugs.
- Write scientific papers on conclusions regarding the efficacy and safety of medicines, and present results in journals and congresses.
- Define and coordinate the training of team members: assistants, clinical trial monitors (CRA), biostatisticians and computer engineers.
- Disclose the latest clinical reports to opinion leaders, academics, experts, scientists and physicians.
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