Study Start Up Associate

Job Summary

Working remotely, the full-time Study Start Up Associate will coordinate clinical trial site start-up activities, manage regulatory document submissions, and support enrollment and closure of clinical trial activities.

Key responsibilities

• Coordinate 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 relationships with clinical research sites to support informed consent form negotiations and customization

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 clinical study site start-up
• Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF
• Ability to multi-task and work in a fast-paced environment
• Clear communication and presentation skills, both written and verbal