Job Title

(Senior) Study StartUp Associate Unique FSP Opportunity | HomeBased in Australia ICON plc is a worldleading healthcare intelligence and clinical research organization. Were 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. Role: Senior Study StartUp Specialist / Study StartUp Specialist II (FSP) Location: Homebased, Australia We are currently seeking a Study StartUp Associate to join our diverse and dynamic team. In this role at ICON, you will work within a largescale, fastpaced FSP environment, supporting the Study StartUp Team Lead in the planning and execution of country and sitelevel startup activities. Your expertise will be critical in delivering highquality Study StartUp (SSU) activities across assigned countries, ensuring the efficient initiation and progression of clinical trials in compliance with local regulatory and ethics requirements. As the first (Senior) Study StartUp Associate to join this FSP team in Australia, this is a rare opportunity to make a meaningful impact from day one. You will play a key role in shaping local startup practices, contributing regional expertise, and supporting the successful expansion of this partnership. What You Will Be Doing Efficiently drive study initiation: conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities. Provide specialized SSU expertise to study startup team leads and project teams, offering valuable insights to drive success. Ensure regulatory compliance: prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines. Safeguard patient welfare: contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent. Your Profile Bachelors degree (or local equivalent) in a medical, scientific, or related discipline, or equivalent relevant experience. Minimum of 3 years experience in a Study StartUp or Regulatory StartUp role within a CRO, pharmaceutical, or biotechnology organization in Australia. Demonstrated experience with Australian study startup activities, including: HREC / Ethics submissions and approvals Australian regulatory submissions and local requirements Site startup coordination and documentation Strong understanding of local startup processes and stakeholder engagement within Australia. Experience with site contracts and budgets is highly desirable and considered a strong advantage. Ability to work effectively in a fastpaced, matrixed, and collaborative environment. What ICON can offer you: Our success depends on the quality of our people. Thats why weve 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 wellbeing and worklife 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 familys needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your familys wellbeing. Life assurance Flexible countryspecific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. At ICON, inclusion & belonging are fundamental to our culture and values. Were 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 Are you a current ICON Employee? Please click here to apply #J-18808-Ljbffr