Senior Clinical Research Associate (CRA I) – FSP

About the role

Thermo Fisher Scientific is seeking a Senior Clinical Research Associate (CRA I) to join its global clinical research team. This home‑based position supports investigator sites across Australia, applying risk‑based monitoring to ensure protocol compliance, data integrity and patient safety.

Key responsibilities

• Conduct remote and on‑site monitoring visits using a risk‑based approach.
• Apply root cause analysis and corrective actions to address site process failures.
• Perform source data verification (SDR), source data review (SDV) and case report form (CRF) review.
• Assess investigational product inventory and related documentation.
• Document observations in reports and letters, adhering to business writing standards.
• Escalate deficiencies promptly and follow issues through to resolution.
• Maintain regular contact with sites to verify protocol adherence and timely data capture.
• Support investigator payment processing and collaborative issue resolution with project team members.

Required profile

• Proven experience in clinical site monitoring and management.
• Strong knowledge of ICH‑GCP guidelines, applicable regulations and SOPs.
• Ability to work independently in a remote environment while maintaining audit readiness.
• Excellent documentation and communication skills.

Required skills

• Source Data Verification (SDR)
• Source Data Review (SDV)
• Case Report Form (CRF) review
• Root Cause Analysis (RCA)
• Investigational Product inventory management
• ICH‑GCP compliance

What we offer

• Opportunity to contribute to life‑changing therapies on a global scale.
• Flexible home‑based work arrangement.
• Access to Thermo Fisher’s resources for professional development.