General

• Ensure regulatory, ICH-GCP, and protocol compliance
• Evaluate site and staff performance, recommend site-specific actions, escalate key issues, and develop action plans
• Maintain current knowledge of ICH-GCP, regulations, and company SOPs/processes
• Check site and external facilities, equipment, and supplies for adequate trial conduct and expiry dates
• Conduct source document review and verification of site source documents and medical records
• Manage reporting and follow-up of protocol deviations
• Enter observations, status updates, and action items into tracking systems through resolution
• Follow up on escalated adverse event monitoring report queries
• Conduct on-site and remote monitoring activities where permitted by country regulations and the monitoring plan
• Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
• Work closely with the Site Manager, investigators, institutions, and other team members
• Ensure sites follow the study plan and remain ready for inspections

Senior CRA, Site Monitor II

• Participate in immersive learning programs focused on business and technical skills
• Work on projects with clients
• Gain exposure to day-to-day operations
• Contribute to problem-solving by analyzing information from multiple sources, identifying patterns or risks, and proposing practical next steps
• Assist with building, troubleshooting, and validating changes in tools and systems, including integrations, workflows, scripts, dashboards, or configurations
• Collaborate with teammates across functions and potentially regions to coordinate handoffs and meet deadlines
• Communicate progress, raise blockers, incorporate feedback, and adjust work based on stakeholder needs
• Follow established processes, quality standards, and workplace norms
• Comply with security, confidentiality, and policy requirements while using digital tools to improve efficiency

General jobs in Greece

Senior CRA, Site Monitor II

Middleware Software Intern