Inexperienced CRA

---

Job details

Company overview

We are a global leader in biopharmaceutical development based in the United States.
Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.

Responsibilities

• 治験を実施する医療機関や医師の選定
• 治験の依頼・契約
• 治験薬の搬入及び回収
• モニタリング
• GCP、治験実施計画書、SOP に則って治験が進んでいるかを確認
• 直接閲覧（SDV)を実施し、症例報告書とカルテ等が一致しているかを照合し、回収
• IRB（治験審査委員会）への文書提出及び手続き
• 医療機関における保管必須文書が適切に保管されているか確認
• モニタリング報告書作成
• 治験の終了手続き 等

Requirements

• 医療業界での勤務経験１年以上お持ちの方

例：薬剤師、看護師、臨床検査技師、MR、CRC 等

Salary

4.5 - 6.5 million yen

Location

Tokyo