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
Venture healthcare company
Job Description
• Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
• Primary point of contact of trial sites with regards to the conduct of the study/ project
• Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
• Ensure that the sites are adequately trained on the protocol and other study specific requirements
• Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
• Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
• Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
• Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
• Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
• Track site budget and payments
• May be involved in preparation of status reports for clients
• Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
• Act as mentor/coach to more junior staff as necessary
• Travel as necessary according to project needs
• Perform other duties as assigned by line manager
Về cuộc phỏng vấn
Địa chỉ liên lạc
CRA
RGF HR Agent
800 〜 1000 ten thousand JPY