Clinical Trial Coordinator

• Assist the clinical research team, supporting Project Managers, Study Start-up team, Clinical Research Associates, and clinical sites to ensure studies comply with ICH GCP, applicable laws, SOPs, and protocols while respecting budgets and timelines
• Conduct site identification and feasibility activities, including outreach, follow-up, and circulation/collection of feasibility questionnaires and NDAs
• Support internal, client/sponsor, scientific, and other meetings through scheduling, agenda preparation, and meeting minutes
• Perform site start-up activities, including Ethics Committee, Institutional Review Board, and regulatory submissions, plus site contract and budget negotiation
• Maintain relationships with Ethics Committees and Competent Authorities
• Set up, maintain, and perform quality control of Trial Master Files
• Support Investigator Site File preparation and distribution
• Support management of study site supplies
• Support collection and review of site Essential Documents with CRAs
• Communicate with sites regarding questions, protocol/GCP compliance, study progress, and subject accrual
• Support study management throughout the study lifecycle, including project reports, CTMS updates, and study-specific trackers
• Maintain study team training materials
• Support site/vendor invoicing management
• Support CRA follow-up activities
• Support document translation
• Participate in audits
• Perform additional assigned duties