• Must meet all requirements for CPA grade 24 position and have demonstrated proficiency in all relevant areas
• Provide input and assist with harmonization of Clinical Operations databases and tracking tools
• Assist in maintaining clinical information and training of Clinical Operations personnel in the clinical trials management system (GILDA)
• Serves as CTMA back up providing verbal and written communication with study personnel
• Tracks and prepares study-specific information utilizing databases, spreadsheets, and other tools
• Reviews and participates in the quality assurance of data or documents
• Arranges meeting logistics, agendas and assists with minutes
• Interacts with other departments, as directed, to complete assigned tasks
• May assist with monitoring visits under the direct supervision of senior staff
• Assists with the planning and facilitation of investigator meetings and, when applicable, provides onsite support during the meetings
• Knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures
• Must be familiar with Word, PowerPoint, and Excel
• Travel may be required