Duration: 6 Months
Hours per week: 20 (Part-Time)
Description:
Our client is seeking a Clinical Research Associate (CRA) to provide oversight and management of clinical trial execution being conducted by the Client’s designated Contract Research Organization (CRO) in Japan. This role is critical to ensure that the CRO performs in accordance with Good Clinical Practice (GCP), the study protocol, and all applicable regulatory and ethical requirements, including those set by the Pharmaceuticals and Medical Devices Agency (PMDA). The CRA will be responsible for ensuring that the CRO meets sponsor expectations, adheres to project timelines, maintains high-quality standards, and operates in compliance with ICH-GCP and local regulatory frameworks. The CRA will also provide weekly status updates to the Client, summarizing CRO performance, site progress, and any emerging risks or issues
Skills:
- Clinical Research Associate
- CRO Oversight
- Pharmaceuticals and Medical Devices Agency (PMDA)
Education: BS
Japan: Sr. CRA (237829)
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