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.

■企業プロフィール

Fortrea Japanは世界90カ国以上に拠点を有し、従業員数約20,000名を抱えるグローバル企業です。
 

大手製薬企業や新興バイオテックからの依頼を受け、臨床開発業務を実施しており、グローバルスタンダードでの品質水準、臨床試験成績を誇ります。世界最先端の新薬開発に携わってきたノウハウを持ち、オンコロジー（抗がん剤）や希少疾患、ワクチンといったニーズの高いプロジェクトを多数手がけています。

Fortreaは2023年にLabcorpグループから分社化し、臨床開発の専門集団として事業を行っています。

事業の選択と集中を行ったことで、人材への投資や、一人一人の成長を支援する体制が整っています。

■CRO（医薬品開発業務受託機関）事業
非臨床試験、臨床試験、開発計画、薬事コンサルティング事業を行っています。

世界の製薬メーカーをクライアントに持ち、プリファード契約もいただいています。開発・研究拠点を世界各地に持つCROで、医薬品開発事業の総合的なパートナーとして、開発計画から治験関連サービス、医薬品の上市のサポートに至るまで、幅広い専門的なサービスを提供しています。
Fortreaは以下のような価値を世界で提供しています。

・医薬品の臨床試験、承認申請・審査、営業・マーケティング、製造販売後調査まで一気通貫のサービス

・医薬品開発の経験と実績を活かした、開発戦略・コンサルティングサービス

・業務の分業化により、新薬開発の効率化・スピードアップを実現
今後は、臨床試験オペレーション事業を主軸に、薬事（医薬品の承認申請）、ファーマコビジランス（医薬品の安全性情報管理）、およびメディカルライティング（臨床開発および承認申請関連文書作成）にも強みを発揮し、患者様ファーストで事業を展開していきます。

■勤務地

東京オフィス または 大阪オフィス

■当社についてもっと知りたい方へ

当社にエントリーいただいた方に、採用に関する詳細情報をお届けいたします。Applyボタンからエントリーを進めてください。

Job Description:

In-House CRA is an essential member of a clinical project team responsible for the execution of a Clinical Research Project. 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 the Company or Sponsor SOP, and regulatory standards and guidelines applicable. All In-house CRA's tasks are to be conducted in the office or home 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, e.g. 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 the Company or client data management systems, as assigned by management.

- To 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.

- To assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable.

Requirements:

- Bachelor’s degree or above, or registered nurse or certified clinical technologist

Preferable experience/skill:

- Business level English; TOEIC score above 740 during the last 1 year or equivalent

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.

For more information about how we collect and store your personal data, please see our Privacy Statement.