Start-up & Regulatory Specialist II
Full-time
Description
<p><b>Shape the Future of Global Clinical Trials</b></p><p></p><p>Join our dynamic team and lead the crucial start-up phase of impactful clinical trials, with opportunities for international exposure. You'll ensure projects are delivered on time, within budget, and to the highest quality standards, directly contributing to life-changing medical advancements.</p><p></p><p><b>Your Impact:</b></p><p></p><p>· Drive the development and execution of efficient start-up processes.</p><p>· Spearhead site-related start-up activities, ensuring seamless initiation.</p><p>· Collaborate with clients and internal teams, presenting at key meetings.</p><p>· Manage timelines, budgets, and documentation with meticulous accuracy.</p><p>· Ensure regulatory compliance and adherence to the highest ethical standards.</p><p></p><p><b>Your Expertise:</b></p><p></p><p>· Strong clinical research background (4+ years), including proven previous experience with study start-up projects.</p><p>· In-depth knowledge of ICH-GCP guidelines and international regulations (US FDA, MHRA).</p><p>· Excellent communication, leadership, and organizational abilities.</p><p>· Proven ability to manage multiple priorities and inspire teamwork in a virtual environment.</p><p>· Fluency in English and the local language.</p><p></p><p><b>Ready to make a difference? Apply now!</b></p><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>