Who this role is for
You are an experienced, hands-on Clinical Research Associate who takes pride in disciplined execution, clean data, and audit-ready trials. You don’t just monitor studies — you own sitelevel execution and data quality end to end. This role exists to ensure that clinical trials are run exactly as designed, deviations are minimized and corrected, and data stands up to audits, analysis, and publication.
What you will own
1. Site execution & monitoring (primary)
• Own assigned sites from initiation to close-out.
• Conduct SIVs, routine monitoring visits, and COVs per plan.
• Oversee patient recruitment, eligibility verification, informed consent process, and follow-up compliance.
• Design CRFs, and implemented automated quality checks, reducing manual
• processing time.
• Ensure strict adherence to protocols, GCP, ICH, ISO 14155.
• Proactively identify risks, deviations, and non-compliance — and drive resolution.
• Train and support site staff and junior coordinators on protocol procedures, EDC usage, and GCP requirements.
• Collaborate with sponsors, CROs (when applicable), investigators, and data management teams for study oversight and data reconciliation.
2. Data quality & source verification (primary)
• Perform rigorous SDV/SDR to ensure accuracy, completeness, and timeliness.
• Own site-level query management, follow-ups, and closures.
• Ensure source → EDC traceability and contemporaneous documentation.
• Support database lock readiness through disciplined site cleanup.
3. Issue management & CAPAs
• Document deviations, non-compliances, and AEs/SAEs accurately and on time.
• Support CAPA implementation at site level and verify effectiveness.
• Escalate only when necessary — otherwise solve problems at the site.
4. Audit & inspection readiness
• Ensure sites are inspection-ready at all times.
• Support internal audits, sponsor audits, and regulatory inspections.
• Maintain complete, accurate TMF documentation for assigned sites.
5. Collaboration & communication
• Assist in regulatory submissions, IEC/IRB correspondence, SAE reporting, and TMF maintenance
• Work closely with the Clinical Operations & Data Quality Manager on risks, timelines, and site performance.
• Partner with investigators and site staff to improve compliance and data quality.
• Provide clear, timely monitoring reports and follow-through on actions.
What we are looking for Mandatory
• 3-4 years of experience as a Clinical Research Associate.
• Proven hands-on experience in site monitoring and SDV.
• Strong understanding of GCP, ICH, ISO 14155.
• Experience with EDC systems and query management.
• Comfortable independently managing multiple sites.
Good to have
• Medical device trial experience.
• Exposure to audits or regulatory inspections.
• Experience supporting database lock activities.
• Utilize Python and SPSS for data validation, statistical reporting, and workflow automation
• Support investigators in abstract development, scientific presentations, and statistical analysis reporting.
• Contribute to protocol development, manuscript drafting and journal submission processes
Mindset
• Execution-focused and detail-oriented.
• Strong sense of ownership — “my sites, my data.”
• Low tolerance for sloppy documentation or shortcuts.
• Enjoys fixing real problems in real clinical settings.
