FSP Clinical Research Associate I/Clinical Research Associate II - Central Poland

Thermo Fisher Scientific seeks a Clinical Research Associate to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. The role involves remote and on-site visits to assess data accuracy, coordinate with study sites, and support regulatory compliance across multiple trial environments.

Responsibilities

• Conduct remote and on-site monitoring visits to assess protocol compliance and regulatory adherence
• Review source documents, case report forms, and investigational product records for accuracy
• Document observations and escalate deficiencies through formal reports and correspondence
• Maintain regular contact with investigational sites to verify protocol adherence and data recording
• Support trial initiation, investigator meetings, and study closeout activities

Requirements

• Bachelor's degree in life sciences or registered nursing certification
• Minimum 2 years clinical monitoring experience in clinical trials or healthcare
• Oncology monitoring experience
• Strong knowledge of ICH GCP guidelines and applicable regulations
• Fluent English and Polish language skills with excellent written communication
• Proficiency in Microsoft Office and clinical trial management systems
• Critical thinking and root cause analysis skills for problem-solving