Are you an exceptional Clinical Research Associate (CRA) based in Thailand that has independent trial site monitoring experience?
- Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
- Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Site management as prescribed in the project plans
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
- May support in organization of meetings and other tasks as instructed by supervisor
Covance by Lapcorp is committed to providing Clinical Research Associates; the flexibility to work from home, the freedom to grow careers across all phases and areas of clinical trial operations as well as providing technology and processes that help to manage time and workload.
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- In lieu of the above requirement, candidates with two (2) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
- Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Basic understanding of the clinical trial process
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