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【経験CRA】 臨床開発モニター(Clinical Site Manager)(東京・大阪・神戸)

Tokyo, Tokyo, Japan Date posted 05/23/2019 Job ID 53013BR

At Parexel, we believe that the power to work independently and intelligently should be yours every day. Your ability to understand our clients’ needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world.

As a Clinical Site Manager (CRA) within Parexel's Global Monitoring Operations Group, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you're looking for flexibility and work-life balance, we're here to listen and help you move forward with your individual career path.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent

"One thing I enjoy about my job is when I see patients feel better with the new treatments; that is very gratifying. I always think about the pleasure our work can give patients and their loved ones."

- Wagner – Associate Manager, Clinical Operations
 

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

【業務内容】
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。

具体的には以下のような業務を遂行します。

•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
•治験の終了手続きなど

【ジョブタイトルについて】
臨床開発モニターは、一般的には”CRA” (Clinical Research Associate)と呼ばれますが、パレクセルは20181月より、CRAの呼称を"CSM"(クリニカル・サイト・マネージャー = Clinical Site Manager)に変更しました。このタイトルには、「自分が担当する施設に対してパレクセルの代表窓口となり、試験の最初から最後までを責任持って実施する」という意味を込めています。


PAREXEL has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the Clinical Site Manager (CSM), formerly the Clinical Research Associate (CRA), serves as the clinical sites’ direct point of contact. The CSM role offers the opportunity to go beyond the role of a typical clinical monitor. CSMs are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. This includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out.

As a CSM, 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 will 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, please apply to learn more.

Your Key Accountabilities:
  • Act as PAREXEL’s sole contact with assigned clinical sites
  • Use your trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
  • Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact report
  • Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with protocol
  • Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
  • Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
  • Monitor completeness and quality of Regulatory Documentation and perform site document verification

Qualifications

【必須】
CRA経験(経験年数1年半以上)※経験領域・疾患は問いません

【その他】
・グローバル試験に挑戦したい方
・英語を学び、英語力をいかせる環境を求めている方


Your Skillset:
  • Previous relevant work experience preferred
  • Educated to degree level (biological science, pharmacy or other health related discipline)
  • Demonstrates strong interpersonal, written, and verbal communication skills within a matrixed team
  • Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
  • Client focused approach to work; flexible attitude with respect to work assignments and new learning
  • Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s)
  • Work ethically and honestly to promote the development of life changing treatments for patients
  • Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
Our Offer:

Join the best minds in the industry and leverage your expertise to help advance treatments into the hands of those who need them most. This role is an excellent opportunity to enhance your skills and take the lead on client projects.

We look forward to speaking with you and determining how PAREXEL fits into your career journey!

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