Study Start-Up Associate

Job Summary

To support study maintenance and startup activities, the full-time salaried Study Start-Up Associate will serve as the primary contact for investigative sites, ensuring timely collection of essential documents and compliance with regulatory submissions, while working remotely in the United States.

Key responsibilities:

• Collect and track necessary documents for site activation and maintenance, ensuring compliance with ICH/GCP and local regulations
• Assist in the preparation and submission of regulatory documents to IRB/IEC and other authorities, maintaining communication with internal and external stakeholders
• Proactively identify and escalate any risks to meeting project deliverables, while updating study documents and status reports as needed

Required qualifications:

• BA/BS degree with 5 years of experience in pharmaceutical drug development or an equivalent combination of education and experience
• 0-2+ years of experience in clinical trials or related fields
• Working knowledge of ICH guidelines, regulatory authorities, and clinical trial processes
• Proven project management skills and leadership ability
• Fluency in English, with strong interpersonal and administrative skills