Clinical Quality Assurance Consultant
About The Position
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is seeking a Quality Assurance Consultant to partner with one of our sponsors for a late-phase U.S. clinical development program for a GLP-1 class therapy in obesity. This fully remote, hourly 1099 contract role will focus on proactive GCP compliance oversight, inspection readiness, and risk-based quality management across Phase IIb/III clinical trials. The ideal candidate is a seasoned clinical QA professional with hands-on audit experience and demonstrated support of FDA inspection readiness within U.S.-based late-phase trials. ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts.
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.
Nice To Haves
- 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.
Responsibilities
- 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 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.
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What This Job Offers
Career Level
Mid Level
