CRA II - 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...). 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 If you are passionate about clinical research, thrive in a collaborative environment, and seek exciting career growth, we want to hear from you! Learn more about our EEO & Accommodations request here. Originally posted on Himalayas