Overview:
Fortrea is hiring a Senior CRA II to lead clinical site monitoring and management activities in compliance with regulatory standards and SOPs. This role includes oversight of project execution, site performance, and may involve leadership responsibilities such as acting as Lead CRA or Local Project Coordinator.
Location: Northern Poland (Koszalin / Szczecin / Gdańsk)
Key Responsibilities:
- Conduct all phases of site monitoring: pre-study, initiation, routine, and close-out visits.
- Ensure protocol compliance, patient safety, and data integrity.
- Maintain study documentation and ensure audit readiness.
- Serve as lead monitor and manage small-scale projects.
- Support protocol and CRF development, trial reporting, and investigator meetings.
- Oversee SAE reporting and registry management.
- Mentor junior staff and support training initiatives.
Must-Have Qualifications:
- Minimum 3 years of active clinical monitoring experience (excluding unblinded-only roles).
- Previous experience in oncology trials or readiness to monitor oncology studies.
- Scientific education (e.g., MSc, DVM, Pharm, or equivalent in medical, pharmaceutical, biology, biotechnology).
- Based in or willing to work within Northern Poland (Koszalin / Szczecin / Gdańsk).
Additional Requirements:
- Fluent in English and Polish.
- Strong knowledge of regulatory requirements and drug development.
- Valid driver’s license and willingness to travel.
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