
Detail-oriented Clinical Research professional with strong experience in clinical trial coordination, monitoring, and applied healthcare support. Background in pharmacy and clinical research with hands-on experience in hospital-based research coordination, CRA monitoring roles, and behavioral therapy in educational settings. Skilled in patient interaction, documentation, protocol adherence, and multidisciplinary teamwork.
Conducted Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) across assigned study sites
• Evaluated site readiness, investigator qualifications, and protocol understanding before study activation
• Ensured all clinical activities were conducted as per ICH-GCP guidelines and sponsor SOPs
Data Integrity & SDV
• Performed detailed Source Data Verification (SDV) to ensure accuracy between medical records and CRFs
• Reviewed Case Report Forms (CRFs) and EDC entries for completeness, consistency, and protocol compliance
• Identified discrepancies and ensured timely query resolution
Regulatory & Compliance
• Maintained and reviewed essential regulatory documents (ethics approvals, site files, investigator documentation)
• Ensured continuous compliance with ICH-GCP (International Council for Harmonization – Good Clinical Practice)
• Supported audit readiness and inspection preparation activities
Safety & Reporting
• Supported reporting and documentation of Serious Adverse Events (SAEs)
• Ensured timely escalation and accurate documentation of safety-related data
Data Quality & Issue Management
• Monitored clinical trial data for inconsistencies and missing information
• Assisted in query generation, tracking, and resolution with site teams
• Ensured high-quality data output for database lock readiness
ICH-GCP Guidelines Compliance
Source Data Verification (SDV)
Case Report Form (CRF) Review & Electronic Data Capture (EDC)
Protocol Compliance & Deviation Tracking
Regulatory Documentation & Trial Master File (TMF) Management
Serious Adverse Event (SAE) Reporting Support
Site Coordination & Investigator Communication
Clinical Data Review & Query Resolution
Strong Documentation & Reporting Skills