Clinical Project Associate

• 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