Clinical Research Quality Assurance Specialist III

This is a fully remote position, open to applicants in Texas.

📋 Description

• Execute thorough internal audits of clinical research operations, encompassing investigator site files, informed consent processes, source documentation, and data integrity.

• Assess adherence to GCP, ICH guidelines, FDA/EMA regulations, and sponsor specifications.

• Supervise inspection readiness efforts, including conducting mock inspections, and serve as a QA representative during regulatory audits.

• Recognize, assess, and manage quality risks throughout the site network, focusing on key areas for mitigation.

• Create and manage quality enhancement plans to tackle systemic risks.

• Lead root cause investigations and formulate intricate Corrective and Preventive Action (CAPA) strategies.

• Oversee the execution of CAPA, ensure its effectiveness, and communicate results to senior management.

• Design and deploy site-wide quality improvement initiatives in accordance with industry best practices.

• Generate and revise Standard Operating Procedures (SOPs), work instructions, and quality manuals.

• Deliver advanced quality assurance, regulatory compliance, and auditing training to QA team members and clinical staff.

• Guide junior and mid-level QA professionals.

• Function as a subject matter expert in regulatory requirements and provide counsel to clinical operations, regulatory affairs, and other stakeholders.

• Collaborate with internal and external parties to resolve quality-related challenges and maintain trial integrity.

• Prepare detailed audit reports and executive summaries for leadership evaluation.

• Analyze quality metrics to pinpoint trends, improvement opportunities, and areas of excellence.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• Comprehensive understanding of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial procedures.

• Exceptional written and verbal communication abilities.

• Strong attention to detail, along with organizational and planning skills.

• Capacity to maintain quality output while prioritizing and managing various deadlines.

• Proficient in Microsoft Word, Excel, Outlook, and PowerPoint.

• Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or comparable platforms.

• Proven capability to conduct audits and generate comprehensive audit reports.

• Demonstrated experience in leading audits and overseeing regulatory inspections.

• Bachelor’s degree in Life Sciences, Health Sciences, or a relevant discipline.

• 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with substantial experience in a QA leadership position.

• Experience in a multi-site clinical research organization or network.

• Able to sit for extended periods while working at a desk and on a computer.

• Approximately 50% travel, with potential for increased travel during peak times or project demands.

• Must be capable of lifting up to 15 pounds occasionally.

🏝️ Benefits

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