Thermo Fisher Scientific Inc. is a global leader in serving science, with annual revenue exceeding $40 billion. Our mission is to enable customers to make the world healthier, cleaner, and safer. We provide innovative technologies, laboratory solutions, and pharmaceutical services through renowned brands like Thermo Scientific, Applied Biosystems, Fisher Scientific, and PPD.
Join a team where your work contributes to groundbreaking advancements in life sciences, healthcare, and research. Discover a career with purpose at Thermo Fisher Scientific.
Job Description
As a Clinical Research Associate (CRA) – Level I, you will ensure compliance with ICH-GCP guidelines and regulatory requirements while managing essential trial documentation. This remote role involves site monitoring, data verification, and collaboration with investigative sites and project teams.
Key Responsibilities:
✔ Ensure all essential trial documents are complete and compliant with ICH-GCP & regulatory standards.
✔ Conduct on-site & remote monitoring (SDV, SDR, CRF review) to ensure data accuracy.
✔ Track trial progress and update study systems (e.g., Clinical Trial Management System).
✔ Facilitate communication between investigative sites, clients, and project teams.
✔ Assist in investigator payments, site initiation, and close-out activities.
✔ Perform risk-based monitoring (RBM) and implement corrective actions.
✔ Maintain administrative tasks (expense reports, timesheets) accurately.
✔ Support audit/inspection readiness and regulatory compliance.
Qualifications:
✅ Life Science Graduate (B.Sc./M.Sc. in Pharmacy, Biotechnology, Microbiology, etc.).
✅ 1+ year of on-site monitoring experience (preferred).
✅ Strong knowledge of ICH-GCP guidelines and clinical trial processes.
✅ Willingness to travel as required.
✅ Ability to join immediately.
Why Join Thermo Fisher Scientific?
🌍 Global Impact: Contribute to life-changing research and healthcare solutions.
💼 Career Growth: Opportunities for professional development in clinical research.
🏡 Work Flexibility: Fully remote role with standard working hours (Mon-Fri).
🔬 Innovative Culture: Work with cutting-edge technologies and industry experts.
