Location: Bucharest, Romania
Job Type: Full Time
Salary: RON 9,000 – RON 13,000 / month
This may be time for you to join our innovative FSP team as a Clinical Research Associate (CRA) in Romania and be at the forefront of groundbreaking medical advancements in a variety of indications (Oncology, Neurology, Gene Therapy…).
Key Responsibilities:
- Monitor Clinical Trials – conduct site visits to ensure compliance with protocols, regulatory requirements and Good Clinical Practice (GCP)
- Site Management – Serve as the primary point of contact for investigational sites, ensuring smooth study operations.
- Source Document Verification (SDV)– Review and verify accuracy of clinical data collected from study sites.
- Investigator Training and Support – Provide ongoing training to site staff on study protocols and regulatory requirements
- Reporting and Documentation -Prepare monitoring reports, maintain study records, and contribute to overall trial documentation.
Qualifications:
- Life Sciences University degree or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). (Fortrea may consider relevant and equivalent experience in lieu of educational requirements)
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process.
- Fluency in Romanian and in English, both written and verbal.
What We Offer:
- Flexible work arrangements (hybrid /remote options)
- Career growth environment in a supportive environment
- Dedicated Line Manager
- Works directly with a leading sponsor on innovative studies
- Attractive salary and Fortrea benefits