Clinical Trial Assistant

• Support Clinical Operations and study leadership with day-to-day coordination and administration of assigned clinical trials
• Schedule and coordinate study meetings
• Prepare agendas, presentation materials, minutes, action items, and follow-up documentation
• Maintain study trackers, action logs, metrics, dashboards, and other tools used to monitor study progress and deliverables
• Communicate with clinical trial sites about routine study activities and documentation
• Maintain current investigator and site information
• Collect and organize information for site feasibility, site identification, and site selection
• Support study-specific training materials, investigator meetings, site initiation activities, and other study meetings
• Track start-up and site activation, enrollment, monitoring visits, outstanding documents, milestones, and other deliverables
• Identify overdue or potentially delayed activities and escalate risks, issues, or delays
• Support study close-out, including outstanding essential documents, site close-out activities, investigational product documentation, financial disclosures, and other required records
• Prepare, review, route, and track study documents
• Compile and maintain study reference materials and manuals
• Maintain document version control and ensure current approved materials are available
• Maintain study folders, shared workspaces, and electronic repositories
• Support Trial Master File activities, including document collection, filing, quality review, reconciliation, and follow-up on missing or incomplete documents
• Track and collect essential regulatory and study documents, including Form FDA 1572s, Financial Disclosure Forms, investigator qualifications, licenses, and training documentation
• Support clinical trial registry activities
• Assist with third-party vendor coordination and tracking
• Support Sponsor audits, regulatory inspections, TMF reviews, and other quality or compliance activities
• Help develop and revise SOPs, templates, forms, work instructions, and Clinical Operations tools
• Recommend improvements to study processes, trackers, templates, and workflows
• Perform other clinical trial support activities consistent with assigned studies and training and experience

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