Clinical Research Associate 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 CRA I at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programmes. What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation - Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. - Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - University degree in medicine, science, or equivalent - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data - Excellent written and verbal communication in English - Good social skills enabling you to deal with queries in a timely manner - Willingness to travel as required (approximately 60%) 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

• Enabling customers to make the world healthier, cleaner and safer • Join global Regulatory Affairs department, Reg Science team • Lead discussions, coordinate regulatory strategies globally on assigned clinical trials • Provide innovative solutions and global regulatory expertise • Act as liaison with internal and external clients • Arrange, lead, and report on client and regulatory agency meetings

• Responsible for delivery of site activation readiness • Prepare submission dossier for authorities • Provide regular updates on submissions • Maintain project plans and regulatory tools • Partner with site CRA for communication

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF. • May support the clinical team performing Pre-Study Site Visits.