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

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

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