Clinical Trial Operations / Clinical Research Professional at Not specified (Present)
5 years of experience in clinical trial coordination and site management support.
- Coordinated clinical trial activities and supported site management processes to ensure protocol compliance and smooth study execution.
- Supported monitoring visits, site readiness activities, sponsor/CRO communication, and documentation review for ongoing studies.
- Maintained source documents, CRFs, essential documents, screening/enrollment logs, and study records in alignment with GCP requirements.
- Assisted with informed consent documentation, subject follow-up coordination, visit scheduling, and investigator site file maintenance.
- Supported ethics/regulatory submissions, document collection, protocol file maintenance, and training/delegation log tracking.
- Helped resolve data queries in coordination with investigators, monitors, and data management teams.
- Contributed to audit/inspection readiness through accurate documentation control and organized clinical trial file management.
- Provided operational support across multiple Phase III and Phase IV studies in diverse therapeutic areas.
