Clinical Trial Start-Up Associate

Job Summary

Managing clinical trial site start-up activities, the remote Study Start Up Associate will coordinate regulatory submissions, document collection, and support enrollment processes while ensuring compliance with legal and regulatory standards.

Key responsibilities

• Coordinate all necessary activities for site regulatory submissions and essential document collection for clinical research sites
• Manage multiple sets of essential regulatory documents across several studies and division portfolios
• Develop and maintain relationships with clinical research sites to support informed consent form negotiations and ensure investigator readiness

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 in the US
• Experience with clinical trial management systems and clinical document control systems
• Ability to multi-task in a fast-paced environment while supporting several studies simultaneously
• Clear communication skills, both written and verbal, with comfort in interacting with clinical research site personnel