Clinical Research Associate

4/2015 – 3/2020

• Conducted Initiation, monitoring and close-out visits in different sites in France, Germany and Austria.
• Evaluated electronic data capturing systems for adherence to guidelines
• Checked drug storage procedures for compliance with protocols and SOP requirements
• Monitored collection, accuracy and integrity of regulatory documents in site binder
• Reviewed participant eligibility and documentation of consent
• Verified data on CRF s, monitor schedules ; file and collectrial documentation and reports, archive documention and correspondance, preparing final report
• Prepared and submitted study documents to competent authorities and ethics committees
• Managed the progress of assigned studies by tracking regulatory submissions and approvals, and data query generation and resolution.

Microsoft Windows (allg.)