CRA 2
On-site · Bangkok, Bangkok, Thailand
Job Summary
Lead CRA responsible for on-site clinical monitoring across trials in Bangkok, ensuring adherence to SOPs, ICH GCP, and Sponsor requirements. Duties include pre-study and initiation visits, routine monitoring, data verification (SDV), query resolution, source document review, regulatory document management (eTMF), Investigational Product inventory control, audit readiness, and travel to study sites (travel ~60%). The role includes preparing monitoring plans and site initiation slides, training new staff, assisting with investigator recruitment, and maintaining trial-management tools. Requires a university/college degree or allied-health certification and at least 2 years of clinical monitoring experience; strong knowledge of monitoring procedures, regulatory requirements, and data integrity; proficient in English and local language; capable of working with minimal supervision and collaborating with cross-functional teams.
Required Qualifications
- University or college degree, or certification in a related allied health profession (e.g., nursing licensure)
- Minimum of 2 years of Clinical Monitoring experience (external candidates) or equivalent experience (internal candidates)
- Ability to monitor study sites independently according to monitoring plan, SOPs, and ICH GCP guidelines
- Proficiency in ICH GCP guidelines and local regulatory requirements
- Fluency in English (written and verbal) and local office language
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