Clinical Trial Assistant

Job Summary

Supporting the execution of clinical studies, the full-time remote Clinical Trial Assistant will provide operational and administrative support across gene therapy development programs, ensuring compliance with ICH-GCP guidelines and facilitating collaboration among cross-functional teams.

Key responsibilities

• Provide operational and administrative support for global clinical studies across multiple gene therapy programs and phases
• Assist with Trial Master File (TMF) management activities, including document collection, quality review, and maintenance of inspection readiness
• Coordinate clinical meetings and support vendor oversight activities, including tracking deliverables and operational documentation

Required qualifications

• Bachelor's degree in life sciences, healthcare, biology, nursing, public health, or related discipline preferred
• 1-4 years of experience supporting clinical research or clinical operations in pharmaceutical, biotechnology, or healthcare environments
• Knowledge of clinical research regulations, ICH-GCP guidelines, and essential clinical documentation preferred
• Experience with clinical systems such as CTMS, eTMF, or related platforms preferred
• Strong organizational and project coordination skills with exceptional attention to detail