
CRA II - FSP, Romania
CMA Fortrea Patient Access Inc.
๐ท๐ด Romania
Remote
2 months ago
- GCP
- ICH-GCP
2 months ago
Not enough detail in this posting to match
This may be time for you to join our innovative FSP team as aClinical Research Associate (CRA) in Romaniaand 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.
โโQualifications:
- Life Sciences University degreeorcertification 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 ofICH GCP Guidelines and understanding oflocal regulatory requirements.
- Thoroughknowledge 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!
#LI-Remote#LI-Hybrid
Learn more about ourEEO & Accommodations request here.
CRA II - FSP, Romania ยท CMA Fortrea Patient Access Inc.