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Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO)-Ilisia
Job Responsibilities:
As a CRA you will:
- Prepare submission packets for hospital ethical committees (ERBs) and administrative boards, the National Ethics Committee (EED), and the National Organization for Medicines in Greece (EOF) for protocol approval
- Be responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations, and Standard Operating Procedures
- Perform monitoring activities from pre-study start-up to study close-out. This may include, but is not limited to, conducting site facilities inspections, site initiation visits, on-site study specific training, ensuring completeness and quality of on-site files, electronic case report forms (eCRF) review, query generation and resolution, monitoring patient safety (adverse events, serious adverse events), addressing protocol deviations, and completing monitoring reports (as applicable)
Minimum requirements:
- University/college degree in scientific or healthcare discipline, or comparable
- 2+ years clinical research experience (prior pharmaceutical industry/contract research organization experience relating to clinical monitoring is a plus)
- Fluency in written and verbal English and Greek
- Computer literacy, including Microsoft Word, Excel, and PowerPoint
- Prior database experience
- Solid understanding of ICH-GCP guidelines
- Strong communication skills and attention to detail
- Ability to manage sites independently. Proven ability to work independently with minimal supervision
- Ability to anticipate potential issues and take appropriate actions with or without supervision
- Ability to travel approximately 25%-50% of the time to sites within Greece
Work location: Athens, Greece
Employment type: Full-time position
Submit your application until: 26/11/2018
Please send your CV and a cover letter at This email address is being protected from spambots. You need JavaScript enabled to view it..
