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Clinical Research Associate / 臨床開発モニター(2023年新卒)

Parexel International Corporation

Tokyo, Tokyo, Japa

募集職種:

臨床開発モニター(CRA: Clinical Research Associate)

臨床開発モニターは、治験に参加くださる患者さんの人権・安全・福祉を保護しつつ、科学的に実効性のあるデータが得られるよう、関連法規や治験実施計画書に基づき、臨床試験の進行状況の確認や調査を行います。

Your time here

At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.

As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel could be your next home.

What you’ll do Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff. Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol. Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s). Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability. Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification. Qualifications【業務内容】

・治験を実施する医療機関や医師の選定

・治験の依頼・契約

・治験薬の搬入及び回収

・モニタリング

・GCP(Good Clinical Practice)、治験実施計画書、SOP(Standard Operating Procedure)に則って治験が進んでいるかを確認

・直接閲覧(SDV: Source Data Verification)を実施し、症例報告書(CRF: Case Report Form)とカルテ等が一致しているかを照合し、回収

・IRB (Institutional Review Board)への文書提出及び手続き

・医療機関における保管必須文書が適切に保管されているか確認

・モニタリング報告書作成

・治験の終了手続き

【求める人物像】

●倫理観をもって取り組める方

●協調性をもって取り組める方

●社内外の多くの人々とコミュニケーションすることが好きな方

●自ら考え、自ら行動できる方

●新薬を世に出したいという情熱をもって取り組める方

●グローバルなフィールドで活躍したい方

Job posted: 2022-04-29

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