Clinical research monitoring & GCP compliance services
Clinical research support for sponsors and service providers, including CROs and consultants, with focus on operational integrity, document quality, and regulatory compliance.
With a strong CRA background, I offer freelance clinical research monitoring, assistance in QA and compliance tasks, such as audit preparation, CAPA tracking, TMF quality control, and SOP review.
Clinical Operations
Study start-up
Set sites, documents, and approvals in place for trial initiation
- Conduct feasibility study assessments and select sites
- Negotiate study budgets and CTAs
- Prepare regulatory and ethics submissions, including initial approvals and amendments
- Review and harmonize informed consent forms
- Ensure completeness of site start-up documentation
Monitoring & oversight
Safeguard patients, compliance, and study data during conduct
- Ensure safety and well-being of trial participants
- Verify eCRF data against source, manage queries, and track actions
- Identify, address, and escalate protocol deviations
- Review patient safety data, reconcile SAEs, and verify safety notifications
- Ensure proper IMP management across all study sites
Quality Assurance & Control
Clinical quality support
Deliver study quality via document review, audits, and CAPA management
- Review trial essential records for accuracy and completeness
- Review documents and records for audit and inspection readiness
- Identify, track, and escalate quality issues
- Check TMF/CTMS for completeness, filing, and inspection readiness
- Conduct on-site and remote quality visits
- Assist in GCP audits execution and documentation
- Draft audit reports and track CAPAs to verify implementation
Study Operations Support
Process management
Oversee timelines, vendors, and study processes to ensure smooth trial conduct
- Coordinate activities to meet study timelines
- Track vendor deliverables, including laboratories, depots, and translation services
- Proofread internal documents and review controlled translations
- Ensure SOP adherence and implement process improvements
- Train site staff and internal teams on study procedures and documentation standards
Need an experienced CRA for monitoring, audit prep, CAPA tracking, TMF QC, and SOP review?