Marcin Kaczkowski

• Monitoring of clinical studies phase II and III in Oncology, Cardiology, Allergology/Pulmonology, Diabetology, Vaccines Study
• Performed selection, initiation, interim monitoring and close-out visits.
• Reviewing of critical document packages, and informed consent forms.
• Participating in preparing of financial agreement and agreement negotiation.
• Making sure the timely production of high quality clinical data, adhering to the standards set by Sponsor in the Standard Operating Procedures (SOPs) for clinical studies
• Preparing documents for submission for Ethic Committees and Health Authorities.
• Reviewing case report form and involved in data query process. Source data verification.
• Reporting adverse events and serious adverse events.
• Filling and collating trial documentation and reports.
• Liaising with Vendors.
• Performing Study Site personnel training.
• Supplying Sites with study specific supplies and study drugs.
• Training of Junior CRA
• Co-monitoring visits