Clinical Trial Start-Up Associate

Job Summary

Working remotely, the full-time Study Start-Up Associate II will manage clinical trial site start-up activities, including regulatory document preparation and approval, while collaborating with clinical teams and ensuring compliance with legal and regulatory standards.

Key responsibilities

• Coordinate site regulatory submissions and essential document collection for clinical research sites
• Manage multiple sets of essential regulatory documents across various studies and divisions
• Develop relationships with clinical research sites to support the negotiation and customization of Informed Consent Forms (ICF)

Required qualifications

• Bachelor's Degree or equivalent combination of experience and education
• 3+ years of experience in clinical/scientific research with a focus on medical device study site start-up
• Experience with clinical trial management systems and document control systems
• Ability to multi-task in a fast-paced environment
• Clear communication and presentation skills, both written and verbal