Clinical Research Associate/臨床開発モニター(東京・大阪・神戸・在宅可)

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Job details

Company overview

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.

Responsibilities

具体的には以下のような業務を遂行します。

• 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(Good Clinical Practice)、治験実施計画書、SOP(Standard Operating Procedure)に則って治験が進んでいるかを確認
• 直接閲覧（SDV: Source Data Verification)を実施し、症例報告書（CRF: Case Report Form)とカルテ等が一致しているかを照合し、回収
• IRB (Institutional Review Board)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 など

Specifically, we will carry out the following tasks:

• Selection of medical institutions and doctors to conduct clinical trials
• Making requests and handling contracts
• Delivery and collection of investigational drugs
• Monitoring - Confirming whether the clinical trial is progressing in accordance with GCP (Good Clinical Practice), clinical trial implementation protocol, and SOP (Standard Operating Procedure).
• Performing direct viewing (SDV: Source Data Verification), checking whether the case report form (CRF) matches medical records
• Document submission and procedures to IRB (Institutional Review Board)
• Confirming whether documents required to be kept at medical institutions are stored appropriately.
• Monitoring report creation
• Clinical trial termination procedures

 

Requirements

必須:

• CRA経験（経験年数1年以上）　※経験領域・疾患は問いません

その他:

• グローバル試験や、オンコロジー領域に挑戦したい方

Required:

• CRA experience (more than 1 year of experience)  *Regardless of therapeutic area.

Other:

• Those who would like to take on global projects and/or the oncology field

     

Salary

5 - 10 million yen

Location

Tokyo