About this role
Serves as a subject-matter expert in quality assurance and regulatory support for clinical research at Seattle Children’s Research Institute. Guides clinical research team members in adhering to federal regulations, state codes, institutional policies, and IRB oversight requirements when conducting research with human participants.
Reviews, analyzes, and processes clinical research protocols and associated documents for submission to local and commercial IRBs. Assesses regulatory requirements and guidance documents, creates standard operating procedures, and implements practices that ensure data quality, integrity, and documentation standards.
Develops and delivers training to build a culture of regulatory preparedness and quality assurance. Performs quality management activities that protect research participants’ safety while maintaining compliance with applicable research regulations and ICH/GCP guidelines.
Supports the institute’s mission to advance pediatric research through consistent regulatory oversight and continuous improvement of clinical research operations and systems.
Requirements
- Bachelor’s Degree in biological sciences or health related field
- Minimum of two (2) years experience in the pharmaceutical industry or clinical research organization in for-profit or academic setting
- Master’s Degree in biological sciences or health-related field
- At least five (5) years experience in a regulatory role
- Experience in drug and device approval process
- RAPS certification or equivalent
Responsibilities
- Serve as subject-matter expert in quality assurance and regulatory support for clinical research
- Guide clinical research team members in adhering to federal regulations, state codes, institutional policies, and IRB requirements
- Review, analyze, and process clinical research protocols and associated documents for IRB submission
- Assess, analyze, and implement regulatory requirements, policies, and guidance documents
- Create and follow standard operating procedures (SOPs)
- Develop and deliver training and education on regulatory preparedness and quality assurance
- Implement practices to ensure quality of data collection, integrity, and documentation
- Perform quality management activities ensuring participant safety and compliance with ICH/GCP guidelines
Benefits
- Medical, dental, and vision plans
- 403(b) retirement plan
- Life insurance
- Paid time off
- Tuition reimbursement
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