AustinFull TimeHealthcare
Remotely
gcpsdrsite managementregulatory documentationedcsdv21 cfr part 812iso14155
Job Description
📋 Description
- Plan, monitor, and manage trials from setup to site visits
- Visit sites in-person and remotely for protocol compliance
- Collaborate with Clinical Ops, Data Mgmt, Regulatory, QA teams
- Maintain essential regulatory documentation and trial files
- Provide safety event review and data query resolution
- Prepare monitoring reports and follow-ups on timelines
🎯 Requirements
- Bachelor’s degree in life sciences, engineering, or related field
- 5+ years in clinical research; device experience preferred
- GCP (ICH E6), ISO 14155, and FDA regs knowledge
- Experience with EDC systems and trial documentation
- Strong monitoring, site management, and communication skills
- Ability to work independently; up to 30% travel
🎁 Benefits
- Competitive base salary with RSUs
- Comprehensive medical, dental, vision
- Paid holidays and commuter benefits
- 401(k) plan; parental leave; flexible time off
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