Site Start-Up Associate

Key responsibilities: Forecasts submission and approval timelines, providing contingency plans and escalating issues as needed Prepares and submits Central EC/IRB Applications and other regulatory submissions, assisting with issue resolution Negotiates site-specific contracts and budgets, ensuring compliance with sponsor and investigator requirementsRequired qualificationsUndergraduate degree in a clinical, science, or health-related field or equivalent licensed healthcare professional 3+ years of direct study start-up experience Working knowledge of FDA Guidance Documents, EU Directives, and local regulations Detailed understanding of country-specific regulatory requirements for clinical trials Proficient in developing and reviewing informed consent forms and patient documentation