Description
Join Fortrea's innovative FSP team as a Clinical Research Associate (CRA) in Romania, contributing to groundbreaking medical advancements in various indications such as Oncology, Neurology, and Gene Therapy.
Key Responsibilities:
- Conduct site visits to monitor clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP).
- Serve as the primary point of contact for investigational sites to ensure smooth study operations.
- Review and verify the accuracy of clinical data collected from study sites through Source Document Verification (SDV).
- Provide ongoing training to site staff on study protocols and regulatory requirements.
- 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 accredited institution.
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Knowledge of monitoring procedures and the clinical trial process.
- At least 3 years of independent monitoring experience.
- Fluency in Romanian and English, both written and verbal.
What We Offer:
- Flexible work arrangements, including hybrid and remote options.
- Career growth opportunities in a supportive environment.
- Dedicated Line Manager.
- Opportunity to work directly with a leading sponsor on innovative studies.
- Attractive salary and Fortrea benefits.