Clinical Quality Assurance Consultant

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.   Main Job Tasks and Responsibilities:GCP Quality Oversight<ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide independent GCP quality oversight for ongoing Phase IIb/III clinical trials.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Review study documentation for compliance with:</li><ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ICH-GCP</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">FDA regulations (21 CFR Parts 11, 50, 54, 56, 312)</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Internal SOPs and quality standards</li></ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Assess protocol deviations, quality trends, and study-level risk indicators.</li></ul>Audit & Inspection Readiness<ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Conduct remote GCP audits, including:</li><ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">CRO/vendor audits</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">TMF quality reviews</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Process audits</li></ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support FDA inspection readiness activities, including:</li><ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Gap assessments</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Mock inspection preparation</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">CAPA review and effectiveness checks</li></ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Track and trend audit findings.</li></ul>Vendor & CRO Oversight<ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Evaluate CRO quality systems and oversight documentation.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Review vendor audit reports and ensure appropriate follow-up.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide quality input into vendor governance processes.</li></ul>Risk-Based Quality Management<ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Partner with Clinical Operations and functional leads to:</li><ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Identify emerging quality risks</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Assess mitigation strategies</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure documentation supports inspection readiness</li></ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support development and refinement of quality metrics and KPIs.</li></ul>Documentation & Reporting<ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Prepare clear, concise audit reports.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Develop executive summaries and quality trend reports.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Maintain quality documentation tracking tools.</li></ul>  Education, Experience and Skills: <ul><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s degree in Life Sciences or related field.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Minimum 5+ years of Clinical QA experience.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated experience supporting late-phase (Phase IIb/III) clinical trials in the U.S..</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong working knowledge of: ICH-GCP,  FDA regulatory framework, Risk-based quality management principles</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience conducting GCP audits (site, process, and/or vendor).</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Prior involvement in FDA inspection readiness activities.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong documentation and report-writing skills.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ability to work independently in a fully remote environment.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience in metabolic, endocrinology, or obesity programs.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Exposure to GLP-1 receptor agonist development programs.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience in large, multi-site U.S. trials.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience working within sponsor oversight or FSP environments.</li><li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Quality certification (e.g., CQA, RAC) preferred.</li></ul> The Application ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.Who will you be working for?About ClinChoice    ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates.ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key Words: Clinical QA, GCP compliance, Phase IIb/III trials, FDA inspection readiness, Risk-based quality management, GCP audits, CRO oversight, TMF review, CAPA management, 21 CFR regulations, Obesity, GLP-1 class therapy in obesity#LI-VH #LI-Remote #Quality Assurance Consultant # Contract

Clinical Quality Assurance Consultant

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