CRA (Level II) - FSP

Clinical Research Associate (Level II) at Thermo Fisher Scientific responsible for monitoring and managing clinical study sites in Santiago, Chile. The role involves site preparation, regulatory compliance, investigator support, data verification, and ensuring adherence to ICH-GCP guidelines and company procedures throughout the study lifecycle.

Responsibilities

• Prepare, initiate, monitor, and close assigned clinical trial sites in compliance with regulations
• Conduct site qualification visits, regulatory documentation, and submissions to ethics committees
• Train site staff on study procedures, ICH-GCP requirements, and risk-based quality management
• Perform on-site and remote monitoring visits with source data verification and case report form review
• Manage study supplies and drug accountability; resolve data queries and quality issues timely

Requirements

• 0–2 years of relevant clinical research experience
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines
• Degree in scientific discipline or healthcare field
• Strong written and verbal communication skills
• Fluent English language proficiency
• Ability to work independently and manage multiple sites