Clinical Research

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and ensure audit readiness
• Monitor investigator sites using a risk-based monitoring approach
• Identify site process failures and implement corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters
• Escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payments and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and compliant with ICH-GCP and regulations
• Track trial status and provide progress reports
• Maintain accurate and current study systems, including Clinical Trial Management Systems
• Facilitate communication among investigative sites, clients, and internal project teams
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to project publications, tools, process improvements, and other initiatives
• Travel more than 75%

Explore Clinical Research Associate, CRA at Thermo Fisher Scientific. Review requirements and application details.