CRA - Bulgaria and UK
Full-time
Description
<p>Here at Fortrea we are currently recruiting for a CRA II in Bulgaria to cover sites in Bulgaria and UK.</p><p></p><div><h3>Key Responsibilities</h3><ul><li>Manage and monitor clinical trial sites in compliance with Fortrea SOPs, ICH‑GCP, protocol requirements, and applicable regulations, including pre‑study, initiation, routine monitoring, and close‑out visits.</li><li>Ensure subject safety and data integrity through informed consent review, source data verification, issue identification, query management, and timely resolution using Fortrea or sponsor systems.</li><li>Maintain site audit readiness by overseeing regulatory documentation, eTMF completeness, investigational product accountability, and protocol adherence throughout the study lifecycle.</li><li>Collaborate closely with cross‑functional study teams to align monitoring activities with study timelines, deliverables, and quality expectations; act as Lead CRA when assigned.</li><li>Prepare accurate monitoring documentation, visit reports, and contribute to study planning, site training, and investigator meetings as required.</li></ul><h3>Requirements</h3><ul><li>University degree or certification in a life sciences or allied health discipline (or equivalent relevant experience).</li><li>Minimum <b>2 years of independent clinical monitoring experience</b> in accordance with ICH‑GCP and regulatory requirements.</li><li>Strong knowledge of clinical trial processes, monitoring practices, SAE reporting, and data review standards.</li><li>Ability to work independently with minimal supervision, managing multiple priorities in a matrix environment.</li><li>Fluency in English and Bulgarian (written and spoken); willingness to travel extensively (approximately 60%).</li><li>Readiness to travel to the UK regularly.</li></ul></div><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO & Accommodations request here</a><span>.</span></p>