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Ready to be the heartbeat of medical research? Join our client in this Clinical Research position and assist in turning innovative science into life-changing care!
Job Responsibility
Monitor assigned sites for protocol compliance and safety reporting
Review source data, manage monitoring plans, and escalate deviations
Liaise between study team, sites, and regulatory bodies
Maintain detailed monitoring records and trending reports
Requirements
Proven years of independent site monitoring experience, including leading monitoring activities autonomously, managing multiple sites, and owning data quality
Flexibility
Proficiency - CDISC standards, eCRF systems, and regulatory documentation (ICH-GCP)
Self-directed - Be able to thrive without constant oversight with ability to prioritize protocol adherence and communicate proactively with sponsors and sites
Nice to have
Medical device trial independent monitoring experience