Emilia Dmowska

• Responsible for all aspects of study site monitoring including: pre-trial assessment, site initiation visits, routine monitoring and close-out of clinical sites according to Pfizer SOP, ICH Guidelines and GCP
• Monitoring of RA, cardiology, HIV-1 and vaccine studies - phase 2, 3 and 4
• Preparation of complete study documentation for ECs submissions and ensuring Regulatory approvals
• Preparing country and site Informed Consent Documents
• Negotiating study budgets with potential investigators and assisting Pfizer legal department with clinical trial agreements finalization
• Coordination of payments for investigators and institutions
• Cooperation and supervision of Clinical Project Assistants in their duties related to respective studies
• Cooperation with local and global Study Team during the course of the study
• Assisting with training, mentoring, and development of new employees, e.g. co-monitoring
• Responsible for preparing administrative documents related to clinical studies from feasibility to close-out process
• Audit experience: site audit in July 5-6, 2011.