Sr CRA (Level I) - FSP

Thermo Fisher Scientific seeks a Senior Clinical Research Associate (Level I) to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. This remote position in Mexico involves coordinating monitoring activities, conducting site visits, and collaborating with sponsors and investigators across multiple therapeutic areas.

Responsibilities

• Monitor investigator sites using risk-based approach; identify deficiencies and implement corrective actions
• Ensure data accuracy through SDV, SDR, and CRF reviews via on-site and remote activities
• Prepare trial status reports and maintain CTMS documentation per study conventions
• Initiate clinical trial sites, conduct investigator meetings, and facilitate site closeout
• Respond to regulatory audits and inspections; maintain essential documents per ICH-GCP requirements

Requirements

• Bachelor's degree in life sciences or registered nursing certification
• Minimum 3 years of on-site clinical monitoring experience
• Minimum 2 years as lead CRA on oncology or hematology trials
• Strong knowledge of ICH-GCP guidelines and applicable regulations
• Proficiency in risk-based monitoring and root cause analysis
• Excellent written and oral communication skills
• Proficient with Microsoft Office and clinical trial management systems