Lead Clinical Research Associate

Lead Clinical Research Associate (Lead CRA) - Remote - Romania ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a Lead Clinical Research Associate at ICON, you will oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. What You Will Do: Your focus will be on coordinating clinical trial monitoring delivery, resolving issues, and developing team capability. Key responsibilities include: Lead and oversee site management activities, including site selection, initiation, monitoring, and close-out visits, ensuring compliance with study protocols, SOPs, ICH-GCP, and applicable regulatory requirements. Serve as the primary point of contact for the sponsor, ICON CRAs, and clinical sites, providing effective communication, resolving site-level issues, and maintaining strong site relationships to support study success. Provide ongoing oversight of study progress through regular review of study metrics, KPIs, risks, and escalations. Support and guide the CRA team by reviewing monitoring reports, providing regular feedback, and conducting co-monitoring visits as needed Work closely with the Study Manager to ensure alignment on study timelines, deliverables, and quality expectations, contributing to high-quality trial execution. Oversee and support CRA responsibilities related to site performance and subject recruitment. Monitor KPIs and metrics to ensure performance is within expectations, set clear site expectations, and follow up on timely and effective action plans. Mentor and develop CRAs, supporting their professional growth and promoting consistent application of best practices across studies. Your Profile: You will have solid clinical trial monitoring experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: Bachelor's degree in a relevant scientific discipline or healthcare-related field Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively. Extensive experience as a Senior Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials. Prior experience in monitoring of cardiology & obesity clinical trials would be an advantage In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes. Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues. Willingness to travel as required #LI-DS1 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Apply To This Job