Clinical Research Associate / Senior CRA

Roles & Responsibilities
• 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, implement automated quality checks to reduce 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, investigators, and data management teams for study oversight and data reconciliation
• 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
• Document deviations, non-compliances, and AEs/SAEs accurately and on time
• Support CAPA implementation at the site level and verify effectiveness
• Solve problems at the site and escalate only when necessary
• Ensure sites are inspection-ready at all times
• Support internal audits, sponsor audits, and regulatory inspections
• Maintain complete, accurate TMF documentation for assigned sites
• Assist in regulatory submissions, IEC/IRB correspondence, SAE reporting, and TMF maintenance
• Work closely with 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

Qualification
• 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

Experience
• Medical device trial experience
• Exposure to audits or regulatory inspections
• Experience supporting database lock activities
• Utilization of 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

Skills
• Strong execution focus and attention to detail
• Low tolerance for sloppy documentation or shortcuts
• Enjoys solving real problems in real clinical settings

About the Company
Remidio is an innovative healthcare company focused on delivering high-quality solutions in clinical research. The role offers an opportunity to work with a dynamic team, managing clinical trials with a focus on data quality, compliance, and strategic execution.