Clinical Trial Associate

📋 Description

• Support study teams with collection, QC, QA of regulatory docs
• Assist with TMF setup and maintenance per ICH-GCP
• Identify TMF gaps; track outstanding documents across studies
• Communicate with sites and study teams to obtain docs
• Maintain Investigator Site Files (ISFs) with site staff
• Develop and maintain study templates and trackers

🎯 Requirements

• Bachelor's in life sciences or related field or equivalent
• 1-3 years in clinical research/operations or related
• Familiarity with TMFs/ISFs and ICH-GCP basics
• Proficiency with MS Office and Google Workspace
• Strong attention to detail and organization
• Ability to work in fast-paced team environment

🎁 Benefits

• Remote (USA) or hybrid in Bay Area preference
• Travel up to 10-20% as needed