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CRA Level II (Cell Therapy or Oncology Experience)
On-site · Taipei, Taiwan, Taiwan
Job Summary
Clinical Research Associate (Level II) responsible for monitoring investigator sites in cell therapy and oncology trials to ensure protocol adherence, regulatory compliance, and data integrity. Key duties include risk-based monitoring (RCA, SDV, CRF review), site qualification and initiation, handling essential regulatory documents, supporting investigator meetings, coordinating with sponsors and project teams, and maintaining audit readiness. Requires strong knowledge of ICH-GCP, good communication, and the ability to travel frequently (60-80%) while coordinating remote and on-site monitoring activities.
Required Qualifications
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent
- Minimum of 3 years of clinical research monitoring experience
- Experience monitoring Oncology and/or Hematology clinical studies preferred
- Experience supporting Cell Therapy, Gene Therapy, or other advanced therapeutic modality studies is an asset
- Proven clinical monitoring skills
- Ability to attain and maintain knowledge of ICH GCPs, applicable regulations and procedural documents
- Strong analytical and problem-solving abilities (root cause analysis)
- Excellent written and verbal communication skills
- Good organizational and time management skills
- Ability to work independently and in a team
- Proficiency with Microsoft Office and clinical trial management systems
- Strong attention to detail
- Good English language and grammar skills
- Ability to travel frequently (60-80%) and possibly extend overnight stays
- Experience handling regulatory documentation and essential documents
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