Responsibilities:
- Performing site evaluation, initiation, monitoring and close-out visits, plus maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP, and applicable regulations.
- Supporting the development of a subject recruitment plan.
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites.
- Evaluating the quality and integrity of site practices - escalating quality issues as appropriate.
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Assist of country and/or site start up activities, including but not limit to country/site ICF development, preparation of IRB submission package, site contract and budget negotiation, and regulatory documents collection.
- Perform the tasks assigned by line manager.
Qualifications:
Education and Experience:
- A BS (Bachelor of Science) degree in Life Sciences or a related field. Advanced degree is an advantage
Pay: $250,000.00 - $350,000.00 per year
Work Location: Hybrid remote in Hong Kong Island