SrCRA - FSP, Romania
Fortrea · Bucharest
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 understanding of the clinical trial process.
- 3+ years of independent monitoring experience
- 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!
#LI-Remote #LI-Hybrid
Learn more about our EEO & Accommodations request here.