In-house CRA I - Full Service

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
トップグローバルCROであるFortreaの新薬開発の国際共同治験に携わっていただく、東京・大阪勤務の臨床開発モニターを募集しています。
Fortrea Japanではアジア治験を含むグローバル・スタディの経験を豊富に積むことが可能です。
グローバルな環境での臨床開発のキャリアを伸ばしていきたいとお考えの方のご応募をお待ちしています。
グローバル・スタディでの臨床開発サポート グローバルでのアライアンス企業が数社あり、それらのクライアントの国際共同治験プロジェクトのほか、さまざまなクライアントのモニタリングにかかわっていただくことになります。
アジア・パシフィック以外にも、欧米の同じプロジェクト担当者とのコミュニケーションなど、英語スキルも自然と磨かれます。 Fortreaについて 当社はグローバル臨床開発サービスのリーディングカンパニーであり、医薬品、バイオ・テクノロジー業界をサポートしています。人の命を救い、また人生を豊かにする医薬品を人々に送り届けることで、私たちは世界に貢献しています。
この私たちの使命への強い姿勢がFortreaの成長と歴史を作ってきました。私たちの会社は、社員がお互いを鼓舞し、育成し、利用する職場環境を発展させることによって成長してきました。 現在グローバル全体では、90カ国で20000人以上の社員が働いています。
The In-House CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The In House CRA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members.
Activities will be conducted in compliance with Company or Sponsor SOP’s and regulatory standards and guidelines applicable.
All In-House CRA's tasks are to be conducted in the office, and no site visits are expected.
Core responsibilities:

• To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites. - To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
• To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
• Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems, as assigned by management.
• Assist with the coordination of study visits and shipment of drug and laboratory samples.
• To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
• To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable.
• Bachelor degree or above - Or, registered nurse or certified clinical technologist
• Experience of CRA (monitoring studies with medicinal products) at least for 2 years.
• Business level English; TOEIC score above 740 during the last 1 year or equivalent.
  

Preferable experience/ skill:

• Experience of entire study lifecycle; start-up, recruitment/maintenance and close-out.
• Experience of at least one global study.
• QC - Experience of audit or regulatory inspection
  

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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