FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance and Quality Management within clinical research, emphasizing regulatory compliance, risk-based quality assessment, and effective communication with investigative sites and leadership.
Highest-signal resume keywords
Quality Assurance Program ImplementationGCP ExpertiseRegulatory ComplianceQuality by Design FrameworkProcess Auditing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ManagementQuality AuditingRisk-Based ApproachRoot-Cause AnalysisQuality Tools UtilizationPolicy ModificationDeficiency ReportingAudit Record MaintenanceProcess Document DevelopmentQuality Improvement Methods
Soft Skills
CommunicationRelationship ManagementCollaborationEducation
Industry Keywords
Clinical ResearchHealthcareLife SciencesFDA RegulationsGCP Compliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Implement the quality assurance program
- Manage and perform consult/support visits at investigative sites
- Assist with onsite external audits and inspections
- Provide routine quality support for assigned investigative sites
- Develop and maintain relationships with investigative sites and SCRI departments and colleagues
- Monitor and modify policies and procedures
- Utilize quality tools to assess study-operation quality indicators
- Monitor and prioritize quality indicators for all sites using a risk-based approach and Quality by Design framework
- Identify and report quality deficiencies to directors and appropriate colleagues
- Assist in developing and modifying process documents
- Assist with preparing and hosting external audits
- Assist research staff in maintaining regulatory compliance
- Perform process/focused audits of research sites and report findings to leadership
- Ensure timely and appropriate follow-up on deficiencies
- Communicate observations and deficiencies to Site Directors/Managers and study PIs
- Assist sites with root-cause analysis and responses to external audits and CAPAs
- Maintain audit records and reports
- Communicate with clinical-trial monitors and auditors as needed
- Educate staff on quality-improvement methods and industry trends
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor’s Degree required
- Minimum 3 years’ work experience in Quality Assurance, Quality Management, or Quality Auditing, preferably in a clinical research, healthcare or life sciences field
- Expertise in GCP, FDA, and other applicable regulations in a risk-based environment
- Master’s Degree preferred
Benefits
Comp & perks- Comprehensive benefits supporting physical, mental, and financial well-being
- Annual bonus or long-term incentive opportunities may be offered
- Relocation assistance is not available
- Visa sponsorship is not available