Study Start-Up Associate

Job Summary

Serving as the primary point of contact for study sites during start-up, the full-time remote Study Start-Up Associate will manage multiple clinical study protocols, ensuring compliance with regulatory tasks and supporting study deliverables from start-up through maintenance and closeout.

Key responsibilities

• Review and approve site activation packages and informed consent forms for FDA compliance
• Maintain accurate regulatory information and track study documents in eTMF systems
• Ensure timely collection of required documents and escalate study issues as necessary

Required qualifications

• Bachelor's degree in a life science field or equivalent
• 1-4 years of prior experience in oncology clinical trials
• Experience with randomized trials and regulatory document review
• Prior experience in a CRO or pharmaceutical environment preferred
• Informed consent and regulatory document review experience required