° Pre-clinical, clinical and regulatory strategy
° Clinical trial planning, set-up and follow-up
° Subcontractor management (and partners) during the clinical trial
° Clinical budget and invoice management
° Development of clinical trial tools
° Coordination of the development and approval of the clinical trial documents: Protocol, SAP, Data Management Plan, ICF, CRF…
° Clinical trial documentation management…
° Our CRAs, with a background in life sciences or medicine, are the main strength of the clinical operations department and add value to the conduct timely execution of clinical projects
° Our CRAs have strong organizational skills, an eye for detail, good written and oral communication skills and are trained in the ICH GCP guidelines and relevant national and international regulations
° Our CRAs conduct on-site monitoring visits throughout the study to:
>> Ensure quality data, protocol adherence and compliance with regulatory guidelines
>> Monitor drug dispensing procedures and drug accountability, conduct source data verification, data collection, safety reporting, ICF review and resolve data queries
