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

Tokyo, Japan Job ID 53013BR Category Clinical Trials Date Posted 08/06/2022
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Overview

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Flexible
  • Organized
  • Problem-solver
  • Self-starter

About This Role

Job Description:

臨床開発モニターは、治験に参加くださる患者さんの人権・安全・福祉を保護しつつ、科学的に実効性のあるデータが得られるよう、関連法規や治験実施計画書に基づき、臨床試験の進行状況の確認や調査を行います。

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

【取り扱う疾患領域】
•がん、中枢神経、心臓血管、感染症、希少疾患など幅広いなど──取り扱う領域は多岐にわたっています

【その他の情報】
•配属部署: 臨床開発部
•配属オフィス: 東京・大阪(一部在宅可)

Job Qualifications:

【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

【求める人物像】
  ◇チームワークを大切にできる方
  ◇他者と良好な関係を築くのが得意な方
  ◇的確な状況把握と臨機応変な判断力

・・・応募の前に、まずは気軽に話を聞いてみたい方・・・・

合同Web説明会へ申し込む

オンデマンドWebカジュアル面談に申し込む

・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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Potential Career Path

Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

  • APEX CRA
  • CRA I
  • CRA II
  • Senior CRA
  • Project Management
    Subject Matter Expert
    People Management

Employee Insights

TEAM IMPRESSIONS

Female employee leaning on desk with Parexel logo in background Team photo
Larger team photo
Female employee with characters from an amusement park Female employee posing for a photo with beautiful landscape in the background
Team outing at laser tag Male employee with medical mask on sitting at desk with laptop open Team photo in an office setting

Why Clinical Research Associates work at Parexel

Learn About Our Culture

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