Haridas Patel

• Conduct on-site monitoring visits (initiation, interim, and close-out) ensuring GCP compliance.

• Perform source data verification (SDV) and CRF review for protocol adherence.

• Oversee IP accountability, essential document tracking, and regulatory submissions.

• Manage eTMF documentation and ensure timely filing of critical documents.

• Prepare monitoring visit reports, follow-up letters, and escalation notes.

• Support inspection readiness and audit preparation across multiple trial sites.

• Coordinate with project teams, site staff, and sponsors for seamless study execution.

TECHNOLOGIES

CTMS, eTMF, Biznet, KnowledgeNET, Symetric, Microsoft Office Suite, Excel Monitoring Trackers.

• Supported study documentation management, TMF organization, and QC checks.

• Tracked CRFs, safety reports, and maintained study correspondence logs.

• Assisted project managers with site document reviews, supply tracking, and meeting minutes.

• Supported study start-up to close-out documentation ensuring completeness and compliance.

TECHNOLOGIES

Octalsoft eTMF, Excel Document Tracker, SharePoint, Microsoft Word

• Maintained study trackers (SAE, IMP, visit logs) and essential site files.

• Reviewed SAE reports for DCGI, EC, and sponsor submission compliance.

• Managed eTMF filing, document reconciliation, and clinical data flow tracking.

• Coordinated with data management and QA teams for documentation accuracy.

• Ensured compliance with ICH-GCP and protocol requirements across assigned studies.

TECHNOLOGIES

CTMS, eTMF (KnowledgeNET), MS Excel Trackers, Email Audit Logs, PDF QC Tools

• Conducted medical record analysis and assigned ICD codes per WHO standards.

• Maintained confidentiality and data integrity during patient record reviews

TECHNOLOGIES

ICD-10 Coding Software, Excel Coding Database, Audit Tracking Sheets