CRA1
On-site · Taipei, Taiwan, Taiwan
Job Summary
Perform site monitoring and management activities to ensure clinical studies are conducted per the protocol, GCP/ICH, and sponsor requirements. Responsibilities include site monitoring visits (initiation, monitoring, and close-out), supporting site recruitment plans to align with project needs, administering protocol training to sites, assessing site compliance and data quality, tracking regulatory submissions and approvals, CRF completion and data query resolution, maintaining TMF/ISF documentation, and coordinating with study team members to support project execution. May assist in start-up activities and site financial management per trial agreements. Strong communication, organizational, and problem-solving skills are essential.
Required Qualifications
- Bachelor's Degree in scientific discipline or health care preferred
- Equivalent combination of education, training and experience may be accepted in lieu of degree
- Some organizations require CRA training program or prior monitoring experience
- Basic knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Good therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in Microsoft Word, Excel and PowerPoint; ability to use laptop and mobile devices
- Written and verbal communication skills in English
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
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