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Senior Initiation Clinical Research Associate

Japan Job ID R0000023427 Category Clinical Trials Date Posted 06/03/2024
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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

initiation 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
・医療機関版の治験契約書及び覚書の作成
・モニター(CRA)や医療機関と各種調整業務(ICFや費⽤、契約書内容の確認)
・システム(CTMS, e-TMF)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)チェックおよび承認等
・同意説明⽂書の作成(英語作成)と内容チェック(⽇本の規制要件等)
・iCRAⅠ・iCRAⅡの育成・指導

【応募対象】
・CRA経験5年以上(グローバル試験経験者歓迎)
・チームメンバーの育成・指導経験、チームリード・サブリード経験必須
・英語Reading &Writing必須TOEIC650以上⽬安※GCP、業務⼿順書(SOP)、システムは英語表記の為
【歓迎(WANT)】
・CRA経験5年以上で内勤業務を希望されている⽅からのご応募を歓迎
・CRA経験者で1-2年ブランクの⽅相談可能

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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