Обязанности и достижения:
Responsible for site administration and site monitoring in accordance with company SOPs, GCP guidelines and local regulations. Have LTM experience for specific trials.
• Recruit investigators, negotiate terms of financial agreements.
• Obtain approvals of Health Authorities and Ethical Committees, import-export licences.
• Support logistics for drug, supplies, equipment; organize custom clearance.
• Perform opening, monitoring and close-out of clinical sites, conduct visits.
• Maintain study files and documentation.
• Present study progress in ISG meetings.
• Assist in mentoring new employees.
Pioneered implementation of electronic CRFs, performed internal support and knowledge transfer.
Passed independent audit without major findings.
• 2008: Certificate – GCP Basic Course / Brookwood International Academy
• 2007: Certificate – IMPACT training course