Clinical Site Associate / Clinical Trial Associate, Office-based (hybrid) in Sydney Location: Sydney, Australia Work Type: Hybrid Employment Type: Full-time Job Description: Clinical Site Associate / Clinical Trial Associate, Office-based (hybrid) in Sydney 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. Title: Clinical Site Associate / Clinical Trial Associate Location: Sydney (Office-based, hybrid) We are currently seeking a Clinical Site Associate to join our diverse and dynamic team. As a Clinical Site Associate at ICON, you will play a key role in supporting site management activities and ensuring that clinical trials are conducted efficiently, compliantly, and to the highest quality standards. You will work closely with Clinical Research Associates (CRAs), site staff, and cross-functional teams to help drive study start-up, maintenance, and close-out activities. What You Will Be Doing: - Supporting site activation activities, including the collection, review, and tracking of essential documents and approvals. - Maintaining up-to-date site information and status in clinical trial management systems and trackers. - Assisting CRAs and project teams with site communications, follow-up, and resolution of site-level queries. - Coordinating logistics for site visits and meetings, including scheduling, documentation preparation, and follow-up actions. - Ensuring accurate filing and maintenance of essential documents to support inspection and audit readiness. - Collaborating with internal stakeholders to support timely site payment processing and issue resolution. - Contributing to process improvement initiatives and sharing best practices to enhance site support efficiency. Your Profile: - Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience. - Initial experience in clinical research, administration, or a similar regulated environment is preferred. - Strong organisational skills with the ability to manage multiple tasks, priorities, and deadlines. - High attention to detail and accuracy in documentation and data entry. - Effective written and verbal communication skills, with a customer-focused approach to site support. - Proficiency with MS Office and comfort working with electronic systems and databases. - Ability to work collaboratively in a team environment and adapt to changing priorities. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: - Competitive base salary and performance related incentives - Health and well-being 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. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

• Planning, executing, managing, and oversight of clinical studies and projects according to Research ethics guidelines, ISO standards, internal SOPs, and portfolio priorities • Serve as a cross-functional lead within an assigned study portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders • Provide accurate, timely status reports and portfolio-level updates on assigned clinical research studies and projects • Facilitate appropriate documentation to maintain compliance with the AP and Compliance department for HCP transfers of value • Facilitate clinical contract agreements between Arthrex and the Site for studies • Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies • Provide centralized communication and coordination between research sites and internal cross-functional stakeholders • Facilitate site training for data collection clinical research initiatives • Monitor data collection compliance and communicate with sites to optimize data collection • Provide the main line of communication with research sites • Facilitate IRB approval at the site and sponsor level • Oversee and approve site activation activities for studies, ensuring readiness across all functional areas • Collaborate on reviewing protocols, case report forms, and informed consent for clinical studies • Qualify sites for participation in assigned studies • Complete central, remote, and on-site monitoring visits, reports, and follow-up letters • Identify study- and portfolio-level risks or issues, implement mitigation strategies, and develop CAPA plans as appropriate • Works closely with the other clinical research professionals and cross-functional partners to ensure successful study execution • Conduct regular investigator meetings to ensure protocol compliance and site engagement • Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment • Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes

Support operational management of study activities, assist in study implementation, ensure compliance with protocols, and maintain effective relationships with community partners while engaging with families and children for recruitment and data...

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes • Leads RBM strategy meetings and develops study-specific site monitoring plan, aligned with study risk assessment • Ensures monitoring strategies are configured in technology capabilities • Manages Site Monitoring assignments in client's systems • Provides Site Monitoring training and supports the creation and delivery of site monitoring materials • Serves as primary reviewer of site monitoring visit reports • Reviews systems and dashboards to assess site monitoring compliance • Supports site monitoring needs during study conduct • Provides site management back-up as needed while Site Monitors are conducting site monitoring visits • Triggers and manages or conducts Monitoring Oversight Visits • Partners with RBQM Operations team to address unresolving centralized monitoring findings with sites • Performs periodic assessment of site monitoring / RBM compliance KPIs and KQIs