Clinical Research Associate

1/2021 – offen

. Manage and monitor all aspects of clinical trials, ensuring adherence to regulatory
guidelines, protocols, and SOPs.
• Prepare and submit clinical trial applications, amendments, and other regulatory
documents to ethics committees, IRBs, and regulatory authorities.
• Coordinate with cross-functional teams, including clinical operations, quality
assurance, and regulatory affairs, to ensure regulatory compliance throughout the
trial lifecycle.
• Review and maintain essential trial documents, including protocols, informed consent
forms, and clinical study reports, ensuring accuracy and compliance with regulatory
requirements.
• Lead the preparation for regulatory audits and inspection, resulting in specific
outcome e.g. reduced findings, positive audit outcomes.
• Facilitate communication between the sponsor, CROs, and investigational sites to
resolve regulatory and operational challenges.

Gesundheitsmanagement

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.)