ClinChoice is hiring a Clinical Quality Assurance Consultant

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.