Study Start-Up Associate

Job Summary

Working remotely in a full-time capacity, the Study Start-Up Associate will manage the end-to-end coordination of study start-up activities, including site identification, regulatory submissions, and stakeholder engagement while ensuring timely and high-quality project delivery.

Key responsibilities

• Participates in the start-up process through site activation, providing customer service to internal and external parties
• Collaborates on trial feasibility processes and maintains SSU trackers and documentation
• Supports the preparation and execution of regulatory and IRB/IEC submissions and approvals

Required qualifications

• Bachelor's Degree with at least 1 year of experience in a clinical research setting, preferably within a CRO
• Good knowledge of clinical research processes and medical terminology
• Basic understanding of regulatory and IRB/IEC submission processes
• Working knowledge of current ICH GCP guidelines and applicable regulations
• Ability to manage multiple competing priorities within various clinical trials