Tóm tắt công việc
Nghề | Nghề yêu cầu chuyên môn (Tư vấn, Tài chính, Bất động sản, Dịch vụ chuyên môn)/Dịch vụ chuyên môn (y tế, phúc lợi xã hội, giáo dục, hướng dẫn viên) |
---|---|
Ngành | Y tế/ Các ngành y tế khác |
Hình thái tuyển dụng | Chưa phân loại |
Chức vụ | Khác |
Số lượng tuyển dụng | 1 người |
Ngày muốn vào làm | - |
Kỹ năng ngôn ngữ cần thiết |
Tiếng Anh (Giao tiếp kinh doanh) Tiếng Nhật (Thành thạo) |
Ngôn ngữ có thể sử dụng | - |
Thời gian làm việc | Khác |
Ngày nghỉ / Phúc lợi y tế | |
Hỗ trợ xin visa | - |
Nhân viên người nước ngoài | - |
Chi tiết công việc
Company Overview
Global Pharma Maker
Job Description
Communicate with Japan Study Leader and third party vendors as needed.
Conduct site selection activities for verifying adequate qualifications.
Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis.
Ensure input the latest site related information in IMPACT at appropriate timing.
Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations.
Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
Cooperate with resolving the result of SAE reconciliation.
Ensure inspection ready TMF regarding site related documents. In addition to above, Senior CRA also is to
Lead a certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training. Mentor CRAs on monitoring and internal procedures. 【応
Requirements
At least 3 years of CRA experience. Demonstrated leadership capability in a team environment successfully.
Negotiated some complicated issues and/or requirements with site staff.
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research
Về cuộc phỏng vấn
Địa chỉ liên lạc
Sr CRA
RGF HR Agent
700 〜 1000 ten thousand JPY