Clinical Trials Associate

Job Summary

To support the Clinical Operations team, the full-time salaried Clinical Trials Associate will manage and coordinate clinical trial activities from start-up through close-out, ensuring compliance with ICH/GCP guidelines and maintaining Trial Master File (TMF) quality in a remote work environment.

Key Responsibilities

• Independently support and coordinate clinical trial activities, ensuring operational milestones and timelines are achieved
• Serve as the primary owner of TMF quality and inspection readiness, performing ongoing quality control and resolving documentation gaps
• Collaborate with CROs, vendors, and sites to track study timelines, identify risks, and support IRB/IEC submissions

Required Qualifications

• Bachelor's degree in a scientific or healthcare-related field preferred; equivalent experience considered
• 2-3+ years of clinical operations experience in biotechnology, pharmaceutical, or CRO settings
• Experience supporting Phase 1-3 clinical trials
• Hands-on experience with TMF management and clinical systems (eTMF, CTMS, EDC)
• Working knowledge of ICH/GCP and applicable regulatory requirements