• Provides overall support to study sites and clinical project teams engaged in clinical research studies. • Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., ICH-GCP, GPP). • Acts as point of contact for study sites. • Oversees all aspects of study site management to ensure patient safety is protected. • Assesses factors that might affect subject/patient's safety and clinical data integrity. • Independently conducts all forms of site visits, including initiation, routine monitoring, and close-out visits. • Develops and maintains good working relationships with investigators and study staff.

• Provides overall support to study sites and clinical project teams engaged in clinical research studies. • Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • Manages site start up procedures including feasibility and recruitment of potential investigators. • Verifies the process of obtaining informed consent has been adequately performed and documented. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.

• Serve as the primary point of contact between investigational sites and the sponsor • Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out • Ensure site compliance with ICH-GCP, SOPs, and regulations • Maintain up-to-date documentation in CTMS and eTMF systems • Support and track site staff training and maintain compliance records • Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting • Support subject recruitment and retention efforts at the site level • Oversee drug accountability and ensure proper storage, return, or destruction • Resolve data queries and drive timely, high-quality data entry • Document site progress and escalate risks or issues to the clinical team • Assist in tracking site budgets and ensuring timely site payments (as applicable) • Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

Role Description 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. 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; participating in the preparation and review of study documentation and feasibility studies for new proposals as required. - Developing and maintaining strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensuring patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Qualifications - University degree in medicine, science, or equivalent. - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data. - Experience in Clinical Research as CTA or similar roles. - Completed CRA Academy Training is highly desirable. - 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%). - Based in CABA. Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Company Description ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.