Experienced Clinical Research Associate 臨床研究專員(CRA2年以上)
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Description
- Contribute to site initiation, monitoring, close-out and tracking of clinical trial documentation and follow-through at sites on assigned clinical projects in collaboration with Project Managers and/or Assigned Personnel.
- Responsible for reviewing study site progress, maintain metrics on enrollment at site level milestones.
- Perform study monitoring activities including but not limited to source document verification, data review and compliance, data query generation and resolution, and review of regulatory binder and deliverables.
- Obtain and maintain essential documentation in compliance with ICH-GCP, procedural documents and local regulations both in the office and at site.
- Prepare study monitoring reports and finalize the report within specified timeline.
- Proactively identify study-related issues and escalate as appropriate.
- Ensure compliance with company policies and procedures.
- Perform other duties as assigned.