Clinical Research Associate II, Israel - FSP

<h2>Job Overview:</h2><p style="margin: 0px;">We are currently looking for talented <strong>Clinical Research Associates to join our team in Israel</strong>. You would be working within our Flexible Solutions department dedicated to one sponsor/client.</p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong>Responsibilities include:</strong></p><ul><li>All details of site management as prescribed in the project plans</li><li>Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks</li><li>Negotiation of study budgets with potential investigators and cooperation with Labcorp Drug Development legal department with statements of agreements</li><li>Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.</li><li>Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems</li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</p><h2>Experience:</h2><ul><li>Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines</li><li>Excellent understanding of Serious Adverse Event (SAE) reporting</li><li>Ability to resolve project-related problems and prioritize workload for self and team</li><li>You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).</li></ul>