Senior Clinical Research Associate
Core
Ensure performance and compliance of assigned clinical trial protocols and sites within the country, serving as the primary site contact and manager throughout all study phases.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for biopharmaceutical studies
Domain
Biopharmaceuticals / Clinical Research
Required skills
ICH-GCP guidelines, Site Monitoring, Site Management, Protocol Compliance, Adverse Event Reporting, Regulatory Documentation, Site Selection, Feasibility Assessment, Audit Support, Patient Safety
Preferred skills
Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), Cross-functional Collaboration, Mentorship, Site Development
Technologies
Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF)
Responsibilities
Conduct remote and on-site monitoring visits (initiation, routine, close-out) to ensure data accuracy and participant safety; Coordinate study start-up activities and site selection/feasibility; Manage regulatory documentation and ensure compliance with local laws and sponsor SOPs; Communicate with investigators regarding protocol conduct, recruitment, and deviations; Mentor junior Clinical Research Associates and share best practices.
Seniority
Senior, hands-on IC
