Initiation Clinical Research Associate II

2週間前

Chuo City Parexel フルタイム

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

initiation Clinical Research Associate (iCRA)は主に施設選定後から、施設の立ち上げ完了となるまでの期間で、治験施設立ち上げ担当者として初回申請に必要な文書の作成から申請手続きを専任で行います。iCRAが施設と直接コンタクトして申請手続き及び治験薬搬入準備を整え、立ち上げ終了時にモニター(CRA)へ引継ぎます。その後の変更手続き等も担当します。

初回申請の専任部門で手続き関連を実施する事で、経験と効率を高めより早く進めることを目指しています。

(Senior) iCRAの主な役割は、下記のとおりです。

  • 施設手続き関連の担当責任者としてリモート(メール、電話)でコミュニケーション
  • 治験審査委員会/倫理委員会提出用資料の作成
  • 医療機関版の同意説明文書及び付随する書類の作成
  • 医療機関へのIRB申請(電子、紙)
  • 医療機関と各種調整業務(ICFや費用、契約書内容の確認)
  • 社内または社外システム(CTMS, e-TMF等)で治験関連業務のトラッキング
  • 治験薬搬入手続きに必要な文書の要件(各種規制要件,SOP,ガイドライン等)チェックおよび承認
  • 治験審査委員会前の同意説明文書の要件(各種規制要件,SOP,ガイドライン等)レビュー等
  • 日本版 同意説明文書(Japan Country ICF)の作成(英語版)とレビュー(日本の規制要件等)
  • 治験関連文書の翻訳及びValidation
  • iCRAI・iCRAIIの育成・指導※シニアi-CRA

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