Clinical Trials Assistant

Job Summary

Supporting Clinical Operations in a remote full-time capacity, the Clinical Trials Assistant will manage essential documents for clinical trials, assist with study drug release, and participate in investigator meetings while ensuring compliance with regulatory guidelines.

Key responsibilities

• Assist in the preparation and management of regulatory documents, study binders, and training materials
• Monitor clinical trial progress and track essential documents, including filing and quality control of trial master files
• Act as a central contact for the clinical team, facilitating communication and documentation for designated projects

Required qualifications

• BS/BA preferred; high school diploma or equivalent required
• Minimum of 2 years of clinical research experience; one year of Clinical Trials Assistant experience preferred
• General knowledge of clinical research requirements, including GCP and ICH guidelines
• Demonstrated organizational and coordination skills
• Solid understanding of clinical drug development preferred