Clinical Research Associate - CRA 2

<h2>Job Overview:</h2><p style="margin: 0px;"><span>Labcorp, we are much more than a normal CRO.</span><br /><span> </span><br /><span>We were named to Fast Company magazine’s list of 2021 Most Innovative Companies for its leadership in scientific innovation in the fight against COVID-19. Labcorp´s Drug Development Business, formerly Covance, was recognized with the 2020 Global CRO Company of the Year Award by Frost & Sullivan for our capacity to integrate digital technologies, remote monitoring, and telemedicine services to ensure continuity of and decentralizing clinical trials.</span><br /><span> </span><br /><span>We have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.  </span><br /><span> </span><br /><span>Join us and see why we are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.</span><br /><span> </span><br /><span> </span><br /><strong><u>Job Overview<br /><br /></u></strong><span>We are currently looking for talented </span><strong>Clinical Research Associates</strong><span>. </span><br /><br /><strong><u>Responsibilities Include<br /></u></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><ul><li><span>University degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology</span></li><li><span>Thorough knowledge of ICH Guidelines and GCP </span></li><li><span>Fluent English, both written and verbal</span></li></ul><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>