Responsibilities:
1. Act as the main contact between the sponsor and the investigational site for:
61 Selection and assessment of investigational sites and investigators
61 Obtaining EC approval for responsible investigational sites in time
61 Management of responsible investigational sites to ensure the quality and compliance to GCP, JW SOPs, protocol, and applicable regulations/laws.
61 Achieve site milestones on time to ensure the completion of study milestones.
61 Investigational site closure as planned
2. Ensure the protection to subject safety and welfare throughout the clinical trial
3. Verify that source data/documentation and other trial related records are accurate, complete, and integrated
4. Ensure all AE/SAEs been reported and recorded within required timeline to fulfill local regulation requirement
5. Collect, maintain, and archive Trial Master File as requested in time
6. Ensure inspection readiness for the responsible investigational sites
7. Support CSM to complete assigned tasks when requested
Job Required Competencies
1. Clear and accurate communication with internal and external customers
2. Ability to work independently
3. Problem solving capability
4. Can work under pressure
5. Teamwork spirit
Education / Qualifications
1. Bachelor degree or above in medicine, science, or related discipline
2. At least 1 year experience in clinical operation is mandated
3. Basic knowledge in ICH-GCP and China GCP
4. Flexibility to travel when requested
5. Good oral and spoken English
6. Good at Microsoft office software