Study Start-Up Associate

Job Summary

Serving as the primary point of contact to study sites during start-up, the full-time remote Study Start-Up Associate will manage multiple clinical study protocols and be responsible for all regulatory tasks pertaining to assigned studies.

Key responsibilities

• Review and approve site activation packages and informed consent forms for compliance with FDA regulations
• Organize regulatory information, track study documents, and maintain accurate data in appropriate databases
• Ensure timely collection of required documents, escalate study issues, and participate in start-up and Sponsor Kick-Off meetings

Required qualifications

• Bachelor's degree in a life science field or equivalent
• 1-4 years of prior work experience in clinical trials, specifically in oncology
• Experience with randomized trials and regulatory document review
• Prior experience in a CRO or pharmaceutical environment preferred
• Familiarity with eTMF systems and Trial Master File maintenance