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Comprehensive training aimed at developing the operational skills of junior and senior Clinical Research Associates (CRAs).
Dematerialised reconstruction of a monitoring session.
Discrimination of gaps, queries and deviations.
Justification in relation to legislation.
Drawing up an appropriate action plan.
Global and multi-stakeholder project scenarios. Early and late phase design. Multiple data sources.
Multiple fictitious monitoring scenarios. Observation notebooks, source documents, study files reconstructing possible discrepancies encountered in the field.
Adaptive learning, tailored to the identified needs and skills of each CRA learner.
Three levels, three courses corresponding to three levels of technical and personal skills, autonomy and initiative.
With 25 years' experience in the field as CRA and CRA team leader, Catherine, our trainer, is responsible for quality control of the CRA's virtual monitoring, correction and individual feedback, as well as the choice of personalised learning modules based on the identified needs.
The training path comprises three levels that meet the needs of a CRA in terms of business skills and professional development. At each level, the training is individually tailored to the CRA learner.
Simple therapeutic trial, short patient follow-up, limited study procedures, simple medical history, minimal adverse events and few concomitant treatments.
Complex therapeutic trial with amendment, long patient follow-up, multiple study procedures, complex medical history, numerous adverse events and concomitant treatments, fraud.
Remote verification of the conduct of biomedical research without access to the source file and management of the investigative site between site visits.