Clinical Operations

• Support in organizing the study at investigational sites and supporting investigators
• Query study status at sites and document findings
• Train investigators and site documentation staff on the study and the EDC software
• Conduct feasibility assessments for new projects with study sites
• Assist in preparing study documents
• Prepare submissions for regulatory authorities and ethics committees
• Create and maintain the Study Master File
• Support sites in handling queries related to electronic study data
• Correspondence in German and English
• Ship and track documents and study materials to study sites
• Draft and revise study contracts
• Prepare documentation for site compensation/payments
• Organize investigator meetings
• Create presentations, charts and tables

Project Assistant – Clinical Trials

Clinical Project Manager – Project Manager, Clinical Studies