Site Start-Up Associate

Job Summary

To support biotech, medtech, and specialty pharma companies, the full-time remote Site Start-Up Associate II will manage submission timelines, prepare regulatory applications, and negotiate site-specific contracts while ensuring compliance with local and international guidelines.

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 requirements

Required qualifications

• Undergraduate 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