- Conduct Quality visits (onsite/offsite) across clinical trial sites to ensure compliance with orgnization SOP/policy
- Review source documents, EDC, study logs, trackers, and essential records with compliance to the protocols, SOPs, GCP, Sponsor/CRO requirements, and applicable regulations for accuracy, completeness, timeliness, traceability, and ALCOA compliance.
- readiness of sites for monitoring, audit, and inspection through periodic QC visits, observation tracking, root-cause analysis, and. CAPA closure.
- Maintain QC reports and compliance trackers, identify recurring quality risks, recommend preventive actions & trainings to the operation team, and escalate significant data-integrity or regulatory concerns.