Bartosz Lisowski

Working as a Freelance CRA for Bayer Health Care. Responsible for all monitoring activities in cardiology studies.

Monitoring activities from start-up, feasibility to close out.

• Monitoring the conduct of clinical trials, especially enrollment and data quality;
• Verification of the safety of the subject and the compliance of the site with FDA Regulations and ICH/GCP Guidelines;
• Ensuring that Adverse Events are reported appropriately, accurately and in a timely manner and follow-up activities are conducted as necessary;
• Reviewing CRF, Informed Consent Documents and queries;
• Specific clinical and therapeutic knowledge related to studies coordinated;
• Conducting pre-study, initiation monitoring and closeout monitoring visits;
• Ensuring complete and thorough study of the drug accountability logs;
• Managing site master file contents;
• Providing support and timely follow-up for all audit and quality assurance activities.