仕事概要
| 職種 | 専門職（コンサルタント、金融、不動産、専門サービス）／専門サービス（医療、福祉、教育、インストラクター） |
|---|---|
| 業種 | 医療／ その他医療 |
| 雇用形態 | 未分類 |
| ポジションレベル | その他 |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 |
英語 （ビジネスレベル） 日本語 （流暢に話せるレベル） |
| 活かせる語学 | - |
| 勤務時間 | その他 |
| 福利厚生・休暇 | |
| ビザ取得支援 | - |
| 外国人従業員 | - |
仕事詳細
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
面接について
連絡先
CRA
RGFタレントソリューションズ株式会社
800 〜 1000 万円
