Clinical Quality Assurance Consultant
ClinChoice
contract
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- Provide independent GCP quality oversight for ongoing Phase IIb/III clinical trials.
- Review study documentation for compliance with: ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), Internal SOPs and quality standards.
- Assess protocol deviations, quality trends, and study-level risk indicators.
- Conduct remote GCP audits, including: CRO/vendor audits, TMF quality reviews, Process audits.
- Support FDA inspection readiness activities, including: Gap assessments, Mock inspection preparation, CAPA review and effectiveness checks.
- Track and trend audit findings.
- Evaluate CRO quality systems and oversight documentation.
- Review vendor audit reports and ensure appropriate follow-up.
- Provide quality input into vendor governance processes.
- Partner with Clinical Operations and functional leads to identify emerging quality risks, assess mitigation strategies, and ensure documentation supports inspection readiness.
- Support development and refinement of quality metrics and KPIs.
- Prepare clear, concise audit reports, develop executive summaries and quality trend reports, and maintain quality documentation tracking tools.
Requirements
- Bachelor’s degree in Life Sciences or related field.
- Minimum 5+ years of Clinical QA experience.
- Demonstrated experience supporting late-phase (Phase IIb/III) clinical trials in the U.S..
- Strong working knowledge of: ICH-GCP, FDA regulatory framework, Risk-based quality management principles
- Experience conducting GCP audits (site, process, and/or vendor).
- Prior involvement in FDA inspection readiness activities.
- Strong documentation and report-writing skills.
- Ability to work independently in a fully remote environment.
- Experience in metabolic, endocrinology, or obesity programs.
- Exposure to GLP-1 receptor agonist development programs.
- Experience in large, multi-site U.S. trials.
- Experience working within sponsor oversight or FSP environments.
- Quality certification (e.g., CQA, RAC) preferred.
Benefits
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCP quality oversightclinical trialsICH-GCPFDA regulationsprotocol deviationsGCP auditsquality metricsKPI developmentdocumentation trackingrisk-based quality management
Soft Skills
independent workreport-writingcommunicationproblem-solvingattention to detailorganizational skillscollaborationanalytical skillsquality assessmentemerging risk identification
Certifications
CQARAC