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パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Clinical Research Associate II

求人ID 62390BR ロケーション ミラノ, Lombardia 仕事内容
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

Your Skillset:
  • Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
  • 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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