Clinical Research Associate II / 臨床開発モニター(東京・大阪・神戸)

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。

•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

＜このポジションの魅力＞

•自分自身のキャリアの幅が広がる。

•製薬会社の重点開発戦略の開発経験を積める。

•CRO側とは、異なる角度からの見方や経験を積める。 ​​​​​​​

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 doLeverage 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•CRA経験（直近1 年以上モニタリング業務に従事）　※経験領域・オンコロジー、免疫、神経、感染症など

•英語：文書読解、作成能力

More about you

On your first day we’ll expect you to have:Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.Ability to perform all clinical monitoring activities independently.Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.Strong interpersonal, written, and verbal communication skills within a matrixed team.Experience working in a self-driven capacity, with a sense of urgency and limited oversight.A client-focused approach to work and flexible attitude with respect to assignments/new learning.The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).An honest and ethical work approach 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.A little about us

Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.