CRA II - FSP, Romania
RemoteBucharest, București, Romania or Romania
Job Summary
Clinical Research Associate (CRA II) in Romania with hybrid/remote options. Responsibilities include monitoring clinical trials to ensure protocol and regulatory compliance (GCP/ICH), site management as primary contact for investigational sites, source document verification (SDV), investigator training and ongoing support, and reporting/documentation of trial activities. Qualifications require a Life Sciences degree or related allied health certification, knowledge of ICH GCP and local regulatory requirements, familiarity with monitoring procedures, and fluency in Romanian and English. The role offers hybrid/remote work arrangements and collaboration with a leading sponsor on innovative studies, with a salary package described as attractive.
Required 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 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
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