Clinical Research Associate II/ Sr CRA, Estonia
- All details of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- Proven on-site Clinical Monitoring experience
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Thorough knowledge of monitoring procedures
- Basic understanding of the clinical trial process
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team
- You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
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