OVERSIGHT MONITOR

Specialized focus also in training Oversight Monitors. This is a highly specialized emerging field. I can help train experienced CRAs to be effective Oversight Monitors... Oversight Visits and QA of monitor activities and site performance to include CRF checks, thorough AE/SAE reporting, protocol adherence, IRB requirement adherence, completeness of regulatory binder, accurate IP handling and accountability, staff and site assessment, proper informed consent rendering and records, patient safety and quality of source and data collection as well as GCP/ICH guidelines. Work closely with Sponsor to ensure high quality monitoring, monitor reporting, trial execution and site relationship.