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, IRB submissions, and site informed consent form negotiations, while ensuring compliance with legal and regulatory standards.

Key responsibilities

• Coordinate site regulatory submissions and essential document collection for clinical research sites
• Develop and maintain relationships with clinical sites to support informed consent form negotiations
• Track and manage regulatory document timelines to achieve target IRB/EC deadlines

Required qualifications

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