Clinical Research Associate / Senior - FSP - Remote

<p><b>When our values align, there's no limit to what we can achieve.</b><br/> <br/>At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.</p><p></p><p></p><p>Parexel FSP is hiring for two experienced CRA's at either the CRA II or Senior CRA level to join one of a large Sponsor’s in the EU.  </p><p></p><p>This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution</p><p></p><p><b>Some specifics about this advertised role</b></p><p></p><ul><li><p>Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.</p></li><li><p>Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.</p></li><li><p>Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.</p></li><li><p>Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.</p></li><li><p>Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable</p></li></ul><p></p><p><b>Who are Parexel</b></p><p></p><p>Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.</p><p></p><p>We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.</p><p></p><p>You’ll be an influential member of the wider team.</p><p></p><p><b>What we are looking for in this role</b></p><p></p><p>For every role, we look for professionals who have the determination and courage always to put patient well-being first.</p><p></p><p>That to us is working with heart.</p><p></p><p><b>Here are a few requirements specific to this advertised role</b>.</p><p></p><ul><li><p>Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent</p></li><li><p>Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations</p></li><li><p>Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)</p></li><li><p>Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases</p></li></ul>