CRA - Office - Osaka / Tokyo

ICON plc is a world-leading healthcare intelligence and clinical research organization.

We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking an IHCRA (In-House Clinical Research Associate) to join our diverse and dynamic team.

As an IHCRA at ICON, you will play a pivotal role in supporting the execution and management of clinical trials, contributing to the advancement of inNvative treatments and therapies.

What You Will Be Doing

Assisting in the planning, initiation, and execution of clinical trial activities
Conducting site feasibility assessments and participating in site selection processes
Coordinating with investigative sites to ensure compliance with study protocols and regulatory requirements
Monitoring study progress and data collection activities to ensure quality and accuracy
Assisting in the preparation and review of study documentation and reports

Your profile

Bachelor's degree in a relevant field, such as life sciences or healthcare
Previous experience in clinical research or a related field preferred
Strong organizational and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Attention to detail and ability to prioritize tasks effectively

【職務概要】

グローバルまたはローカル試験における、臨床開発モニター業務をお任せいたします。

医療機関で実施される新薬の臨床試験(治験)が、適切に実施されているか(被験者さん安全と人権が確保されているか)をモニタリングするお仕事です。

※ご入社後、一定期間内勤モニター業務をご担当いただく場合があります。

【臨床開発モニター業務について】

・治験施設との臨床試験契約の交渉と管理

・必須文書の収集・レビュー・管理およびクローズアウト

・クリニカルサプライ、パートナー(ベンダー)および社内関係チームとの連携

・被験者のスクリーニングおよび登録のサポート

・専用システム(CTMS等)を使用した費用請求・支払の対応

・トラッキングレポートの作成

・担当する試験の進捗状況についてオンサイトまたはオフサイトでモニタリングし、治験実施計画、SOPs、ICH/J-GCP、その他の適用される法規則に沿って、試験が実施、記録、報告されていることを確認する

・医療機関との契約交渉、締結に責任を有する

・他のクリニカルチームメンバーと緊密に連携して、発生した試験実施上の問題解決を図る

・経験の浅いメンバーに適切な指導を与え、メンバーの成長に貢献する

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits.

Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply
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