Job Summary
A molecular diagnostics company is filling a position for a Remote Senior Clinical Quality Associate.
Core Responsibilities of this position include:
- Providing guidance to Clinical Affairs to ensure adherence to all regulations
- Drafting, reviewing, and revising Clinical SOPs and assessing consistency across internal processes
- Performing Quality Control review of study documents
Must meet the following requirements for consideration:
- Ability to travel 30% of working time away from work location
- Bachelor’s degree in the life sciences or a related field
- 6+ years of experience in clinical research
- 5+ years of experience implementing ICH GCP E6 R
- 4+ years of experience in Clinical Operations or in a Clinical Quality Assurance role
- 4+ years of experience with CTMS, EDC, eTMF, and sample management systems
