Site Activation Specialist

Job Summary

Supporting site activation and maintenance activities, the full-time remote Site Activation Specialist will coordinate regulatory document collection, ensure timely completion of start-up activities, and drive quality assurance efforts to facilitate successful clinical trial execution.

Key responsibilities

• Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents
• Partner with study teams and stakeholders to ensure timely completion of start-up activities and activation milestones
• Review study-specific regulatory documentation, identify gaps, and drive corrective actions prior to final approval

Required qualifications

• Bachelor's degree in a related scientific discipline with at least one year of clinical research experience
• Previous experience in the pharmaceutical, biotechnology, or CRO industry
• Working knowledge of ICH GCP and other relevant clinical research regulations
• Strong understanding of clinical research processes and regulatory documentation requirements
• Proficiency with Microsoft Word, Excel, PowerPoint, and other digital systems