North AmericaFull TimeHealthcare
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
regulatory compliancegoogle workspaceregulatory documentationtmfich gcptrial master fileisfs
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Job Description
📋 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
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