Job Description

Thermo Fisher Scientific seeks an experienced Clinical Research Associate to monitor oncology trial sites, ensure regulatory compliance, and manage documentation across remote and onsite visits. The role involves coordinating with investigator sites, applying risk-based monitoring approaches, and maintaining data integrity for clinical trials.

Responsibilities

• Conduct remote and onsite monitoring visits to assess regulatory compliance and site adherence to protocol
• Review source documents, case report forms, and investigational product records to ensure data accuracy
• Identify site process failures and implement corrective and preventive actions
• Generate timely monitoring reports and escalate deficiencies to clinical management
• Maintain communication with investigator sites between visits and coordinate trial initiation and closeout activities

Requirements

• Bachelor's degree in life sciences or registered nurse certification
• Minimum 1 year oncology monitoring experience OR 2 years standard monitoring with clinical background
• Strong understanding of ICH GCP guidelines and applicable regulations
• Critical thinking and root cause analysis skills for problem-solving
• Excellent written and oral communication abilities
• Proficiency with Microsoft Office and clinical trial management systems
• Attention to detail and organizational skills

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