ClinChoice is hiring a Clinical Quality Assurance Consultant to provide proactive GCP compliance oversight, inspection readiness, and risk-based quality management for a late-phase U.S. clinical development program for a GLP-1 class therapy in obesity. This is a fully remote, hourly 1099 contract role.
What You'll Do
- 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), and internal SOPs.
- Assess protocol deviations, quality trends, and study-level risk indicators.
- Conduct remote GCP audits, including CRO/vendor audits, TMF quality reviews, and process audits.
- Support FDA inspection readiness activities, including gap assessments, mock inspection preparation, and CAPA review.
- 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.
- Maintain quality documentation tracking tools.
What We're Looking For
- Bachelor’s degree in Life Sciences or a related field.
- A minimum of 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, and 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 large, multi-site U.S. trials.
- Experience working within sponsor oversight or FSP environments.
Nice to Have
- Experience in metabolic, endocrinology, or obesity programs.
- Exposure to GLP-1 receptor agonist development programs.
- Quality certification (e.g., CQA, RAC).
Team & Environment
This is a client-facing role, working directly for a single sponsor while employed by a global CRO.
Work Mode
This is a fully remote, hourly 1099 contract position.
