Clinical Research Associate / Senior Clinical Research Associate - Denmark (Zealand) or Sweden (Malmö)

<p>At Fortrea, we are committed to transforming the development of life-saving and life-enhancing treatments. As a Clinical Research Associate , you will play a key role in advancing clinical trials by ensuring high-quality site management and monitoring activities. Join our collaborative and empowered team where your expertise will help bring innovative therapies to patients faster.</p><p></p><p><span><b>Your Responsibilities</b></span></p><p>As a CRA based in Denmark (Copenhagen area) or Sweden (Malmo area) , you will be responsible for overseeing clinical study sites to ensure adherence to study protocols, Good Clinical Practice (ICH GCP), Fortrea SOPs, and local regulatory requirements. Key duties include:</p><ul><li><p>Conducting all types of site visits: Pre-study, Site Initiation, Routine Monitoring, and Close-out Visits.</p></li><li><p>Verifying that informed consent procedures and protocol requirements are consistently followed to protect study participants.</p></li><li><p>Monitoring data quality through source document review and verification, identifying discrepancies, and initiating corrective actions as needed.</p></li><li><p>Ensuring site regulatory documentation and essential files (e.g., eTMF) are accurate and up to date throughout the trial.</p></li><li><p>Maintaining investigational product (IP) accountability and ensuring compliance with protocol storage and handling procedures.</p></li><li><p>Supporting site audit readiness and meeting study timelines and metrics.</p></li><li><p>Serving as Lead CRA when assigned, providing mentorship and guidance to colleagues.</p></li><li><p>Preparing detailed monitoring visit reports and maintaining up-to-date trial documentation using Fortrea or sponsor systems.</p></li></ul><h3></h3><p><span><b>Minimum Qualifications:</b></span></p><ul><li><p>Bachelor’s degree (or equivalent) in Life Sciences, Nursing, Pharmacy, or related field; relevant clinical research experience may be considered in lieu of formal education.</p></li><li><p><b>Minimum of 2 years of independent clinical monitoring experience</b>.</p></li><li><p>In-depth knowledge of ICH GCP and local regulatory requirements.</p></li><li><p>Proficiency in clinical monitoring techniques and the full trial lifecycle.</p></li><li><p>Fluent in English (written and spoken); Danish or Swedish</p></li><li><p>Willingness to travel</p></li></ul><p></p><p><span><b>Preferred Qualifications:</b></span></p><ul><li><p>Life Sciences or Nursing degree.</p></li><li><p>Experience with Fortrea SOPs, eClinical systems (e.g., CTMS), and risk-based monitoring approaches.</p></li><li><p>Exposure to multiple therapeutic areas, including early-phase or medical device studies.</p></li><li><p>Strong communication, analytical, and problem-solving skills.</p></li><li><p>Ability to train site staff and mentor junior CRAs.</p></li></ul><p></p><p>​At Fortrea, you’ll be part of a mission-driven team focused on scientific and process excellence. We offer:</p><ul><li><p>A collaborative, global team environment.</p></li><li><p>Access to world-class training, tools, and career development.</p></li><li><p>The chance to make a measurable impact in advancing health care solutions.</p></li></ul><p></p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" rel="noopener noreferrer" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>