Małgorzata Kaczmarzyk

• Assistance in performing study feasibility
• Provides complete study documentation for ECs submissions and ensures regulatory approval in Central Registry of Clinical Trials
• Cooperates and supervise Clinical Project Assistants in their duties related to respective studies
• Maintains regular and effective contacts with study sites
• Provides information to investigators about: protocol principles, study timelines, enrolment expectations and proposed fee
• Provides training for investigators regarding specific study procedures and CRF completion
• Participates in the Investigators’ Meetings, audits and any other events related to the study conduct
• Ensures investigators’ compliance with protocol and study procedures
• Ensures completion and maintenance of study documentation
• Monitors regularly trial progress and ensures timely completion
• Cooperates efficiently with Safety function to manage Adverse Events reporting issues
• Identifies site problems and initiates corrective actions
• Monitors trial drug and other supplies availability and distribution