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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Initiation Clinical Research Associate II

Job ID R0000025482 Tokyo, Tokyo, Japan

■職務内容
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
・ヒアリング/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 や費用の確認等)
・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および文書格納
・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
下記に該当する方からのご応募を歓迎します。
【必須】
i-CRAⅠ
・モニター(CRA)実務経験者目安2 年以上
・・SSU SSU/SMA/CRC
(グローバルスタディ・がん領域経験者歓迎)
i-CRAⅡ
・モニター(CRA)実務経験者目安3~4 年以上
・SSU 経験者歓迎
シニアi-CRA
・モニター(CRA)実務経験5 年以上
・SSU 経験者歓迎
・チームリード、後輩指導や育成経験

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