Aligning values leads to unlimited achievements
Initiation Clinical Research Associate (iCRA) primarily focuses on creating necessary documents for initial applications in collaboration with a CRA, from facility selection to the point where investigational drugs can be delivered to the facility. iCRA reviews and creates documents based on information collected by the CRA through direct contact with the facility. The division of roles aims to efficiently progress the initial application.
Main responsibilities of a Senior iCRA:
- Creation of documents for submission to the study review board/ethics committee
- Development of institutional informed consent forms and accompanying documents
- Preparation of institutional clinical trial contracts and memoranda
- Coordination with monitors (CRAs) and healthcare facilities for various arrangements (review of informed consent forms, costs, contract details)
- Tracking of clinical trial related tasks in systems (CTMS, e-TMF)
- Checking and approval of document requirements for investigational drug delivery procedures (various regulatory requirements, SOPs, guidelines, etc.)
- Review and approval of informed consent form requirements before study review boards (various regulatory requirements, SOPs, guidelines, etc.)
- Creation and content review of informed consent forms (English drafting) in compliance with Japanese regulatory requirements
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Osaka 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 ...
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Osaka Parexel Local Officeinitiation Clinical Research Associate (iCRA)は主に施設選定後から、施設の治験薬搬入可能となるまでの期間で、CRAと共同して初回申請に必要な文書の作成、 · 要件チェックを行います。CRAが施設と直接コンタクトして収集した情報を元に、iCRAが文書を作成及びレビューします。この役割分担システムにより、初回申 · 請を効率よく進めることを目指しています。 · Senior iCRAの主な役割: · ・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 · ・医療機関版 ...
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Osaka Parexel Local Officeinitiation Clinical Research Associate (iCRA)は主に施設選定後から、施設の治験薬搬入可能となるまでの期間で、CRAと共同して初回申請に必要な文書の作成、 · 要件チェックを行います。CRAが施設と直接コンタクトして収集した情報を元に、iCRAが文書を作成及びレビューします。この役割分担���ステムにより、初回申 · 請を効率よく進めることを目指しています。 · Senior iCRAの主な役割: · ・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 ...
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Clinical Team Lead
2週間前
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