Description
Join our innovative FSP team as a Clinical Research Associate (CRA) in Romania and be at the forefront of groundbreaking medical advancements in various indications such as Oncology, Neurology, and 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 the 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).
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process.
- Fluency in Romanian and English, both written and verbal.
What We Offer:
- Flexible work arrangements (hybrid/remote options)
- Career growth environment in a supportive setting
- Dedicated Line Manager
- Work directly with a leading sponsor on innovative studies
- Attractive salary and Fortrea benefits