• Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.
• Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines.
• Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conduct close-out visits.
• Identify site issues and initiates correction plans based on monitoring reports.
• Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.
• Verify data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner.
• Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.
• Verify drug accountability logs and storage requirements.
• Responds to requests from investigative sites in a timely fashion.
• Provide study status updates to team members and project management, including interaction to resolve site
issues and facilitate project timelines.
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