Coordinate and monitor clinical trial activities from site start-up to close-out
Perform on-site and remote monitoring visits in accordance with monitoring plans
Conduct Risk-Based Quality Monitoring (RBQM), including SDV and SDR
Review and manage data in EDC, CTMS, IWRS, and eTMF systems
Ensure compliance with ICH-GCP, SOPs, and regulatory requirements
Maintain audit readiness and support site audits and inspections
Prepare monitoring visit reports and follow-up letters
Track country-level site metrics and proactively resolve issues
Maintain regular communication with investigators and site teams
Support CAPA planning and implementation
Mentor junior CRA team members when required
Travel up to 60–75% as per monitoring plan
Complete timesheets, expense reports, and other trial documentation
Postgraduate degree in Life Sciences or related discipline
Minimum 1–1.5 years of mandatory on-site monitoring experience
Strong working knowledge of ICH-GCP and regulatory guidelines
Experience in FSP model preferred
Hands-on experience with EDC, CTMS, IWRS, and eTMF systems
Valid driving license (where applicable)
Excellent written and verbal communication skills
Stakeholder and site relationship management
High attention to detail and documentation accuracy
Ability to manage multiple studies simultaneously
Strong problem-solving and risk mitigation capability
Independent working with collaborative mindset
Proficiency in MS Office and clinical trial software
Work on global trials across 100+ countries
Exposure to Top-50 pharma and 750+ biotech sponsors
Fully remote work model
Clear career progression from CRA I to CRA II and senior levels
Continuous training and mentoring programs
Strong compliance-driven and quality-focused culture
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