Clinical Research Quality Assurance Specialist III

🕒 6 dias atrás

🤠 Texas – Remoto

🤠 Texas – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Tekton Research

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2006

🏥 Saúde

💼 Consultoria

📦 Logística

💰 Private equity em 2023-10

Healthcare • Consulting • Logistics

A Tekton Research é uma organização de pesquisa clínica com múltiplos sites, sediada em Austin, TX, que conduz ensaios clínicos de Fase 1–4 nas áreas de neurociência, doenças cardiometabólicas, doenças infecciosas e medicina geral. A empresa faz parcerias com patrocinadores, CROs e biofarma para desenvolver medicamentos, dispositivos médicos e diagnósticos, operando uma rede de sites de pesquisa liderados por médicos em vários estados dos EUA com rápida ativação de sites, capacidade dedicada de recrutamento de pacientes e alta retenção de participantes. A Tekton enfatiza o cuidado centrado no paciente enquanto oferece escala operacional para ensaios complexos e de grande volume.

Descrição

• Conduct in-depth internal audits of clinical research activities, including investigator site files, informed consent processes, source documentation, and data integrity • Evaluate compliance with GCP, ICH guidelines, FDA/EMA regulations, and sponsor requirements • Oversee inspection readiness activities, including mock inspections, and act as a QA representative during regulatory inspections • Identify, evaluate, and manage quality risks across the site network, prioritizing areas for mitigation • Develop and oversee quality improvement plans to address systemic risks • Lead root cause analyses and develop complex Corrective and Preventive Action (CAPA) plans • Monitor CAPA implementation, ensure effectiveness, and report outcomes to senior leadership • Design and implement site-wide quality improvement initiatives aligned with industry best practices • Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals • Provide advanced quality assurance, regulatory compliance, and auditing training to QA team members and clinical staff • Mentor junior and mid-level QA professionals • Act as a subject matter expert in regulatory requirements and advise clinical operations, regulatory affairs, and other stakeholders • Collaborate with internal and external stakeholders to address quality-related issues and ensure trial integrity • Prepare comprehensive audit reports and executive summaries for leadership review • Analyze quality metrics to identify trends, improvement opportunities, and areas of excellence • Perform other duties as assigned

🎯 Requisitos

• In-depth knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial processes • Excellent written and oral communication skills • Strong attention to detail, organizational, and planning skills • Ability to maintain quality work while prioritizing and managing multiple deadlines • Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint • Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar platforms • Proven ability to conduct audits and prepare detailed audit reports • Demonstrated experience leading audits and managing regulatory inspections • Bachelor’s degree in Life Sciences, Health Sciences, or a related field • 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with significant experience in a QA leadership role • Experience working in a multi-site clinical research organization or network • Prolonged periods of sitting at a desk and working on a computer • Approximately 50% travel, with possible increased travel during peak periods or project needs • Must be able to lift up to 15 pounds at times

🏖️ Benefícios

• Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand