Major Responsibilities:
1. Acts as the main contact between the sponsor and the investigational site for:
1) Selection and assessment of investigational sites and investigators.
2) Obtaining EC approval for responsible investigational sites in time.
3) Management of responsible investigational sites to ensure the quality and compliance to GCP, JW therapeutics SOPs, protocol, and applicable regulations/laws.
4) Achieving site milestones on time to ensure the completion of study milestones.
5) Investigational site closure as planned.
2. Ensure the protection to subject safety and welfare throughout the clinical trial.
3. Verifies 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. Ensure APH and infusion process are strictly followed at sites.
6. Manages the progress of assigned sites by tracking submissions and approvals, recruitment and enrollment, case report form(CRF) completion and submission, and data query generation and resolution.
7. Collects, maintains and archives Trial Master File as requested in time.
8. Ensure inspection readiness for the responsible investigational sites.
9. Supports study manager to complete assigned tasks when requested.
10. Acts as a mentor of other CRAs including conducting co-monitoring and training visits.
11. Be responsible for study tools, documents and processes development per study manager’s request.
Qualification:
Job Required Competencies
61 In depth knowledge in ICH-GCP and China GCP.
61 Smooth communication with internal and external customers.
61 Ability to work independently.
61 Excellent Problem solving capability.
61 Can work under pressure.
61 Teamwork spirit.
61 Effective time and financial management skills.
61 In depth therapeutic and protocol knowledge as provided in company training.
61 Good mentoring and training skills.
61 Good written and verbal communication in English.
Education / Qualifications
61 Bachelor degree in the scientific or health related field.
61 Typically requires 2-4 years’ of prior relevant experience.
61 Flexibility to travel when requested.