Clinical Research Associate II (CRA2)

<p><b><span class="emphasis-2">Summary of Responsibilities:</span></b></p><ul><li><p>Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.</p></li><li><p>Responsible for all aspects of site management as prescribed in the project plans.</p></li></ul><p></p><p><b><span class="emphasis-2">Qualifications (Minimum Required):</span></b></p><ul><li>University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.</li><li>Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.</li><li>Thorough knowledge of monitoring procedures.</li><li>Basic understanding of the clinical trial process.</li><li>Fluent in local office language and in English, both written and verbal.</li><li>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li></ul><p></p><p><b><span class="emphasis-2">Experience (Minimum Required):</span></b></p><ul><li><b>External Candidates:</b></li><li>University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND</li><li>A minimum of 2 years of Clinical Monitoring experience.</li><li><b>Internal Candidates:</b></li><li>Internal candidates with a minimum of 2 years of Clinical Monitoring experience.</li><li>Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.</li><li>Ability to work with minimal supervision.</li><li>Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.</li><li>Good planning, organization, and problem-solving abilities.</li><li>Works efficiently and effectively in a matrix environment.</li></ul><p></p><p><b><span class="emphasis-2">Physical Demands/Work Environment:</span></b></p><ul><li>Travel Requirement is 60% of the time (traveling to study sites).</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>