SrCRA - FSP, Romania

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...).

• →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.

• 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 understanding of the clinical trial process.
• 3+ years of independent monitoring experience
• Fluency in Romanian and in English, both written and verbal.