Parexel

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

Japan · Work style not stated

Posted over 6 months ago: check it’s still open

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About the role

Description from the employer’s posting. Check the employer’s page for the current version.

  • EmployerParexel
  • LocationJapan
  • Work styleWork style not stated
  • Employer posted

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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

Show full description

【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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At a glance

  • SeniorityEntry level
  • Employer posted
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Skills in this posting

Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.

GCP

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