QA Specialist

Job Overview The Quality Assurance Specialist is responsible for supporting and executing Quality Control (QC) and Quality Assurance (QA) activities across the Avacare Clinical Research network. This role ensures that clinical operations, regulatory documentation, and site processes meet internal quality standards, Good Clinical Practice (GCP) requirements, and applicable regulatory guidelines. The Quality Specialist works closely with site teams, study staff, and the Manager of Site Quality Management to proactively identify quality risks, implement corrective actions, promote audit readiness and drive continuous quality improvement. Essential Functions + u00b7Conduct internal audits of site processes, study documentation, and source records to ensure compliance with GCP, protocols, SOPs, and regulatory requirements. + Assist in developing and maintaining study-level risk assessments + Identify quality gaps, root causes, and trends; support Corrective and Preventive Action (CAPA) development and implementation. + Participate in and/or support sponsor audits and regulatory inspections, either in person or remotely + Maintain quality documentation including audit reports, training records, deviation logs, CAPA plans, and Quality metrics. + Perform routine QC checks on informed consent documentation, AEs/SAEs, source records, investigational product accountability, protocol deviations, and data entry. + Verify accuracy and completeness of clinical trial documentation. + Conduct ongoing review of study workflows to confirm adherence to protocol requirements and internal SOPs. + Collaborate with site staff to ensure that QC findings are understood, corrected, and prevented in future workflows. + Track and report key quality metrics and trends to the Manager of Site Quality Management. + Contribute to process improvements aimed at enhancing data integrity, subject safety, and regulatory compliance. + Lead or support quality-related projects as assigned. Qualifications + Bacheloru2019s degree in health sciences with 1-3 years relevant experience or High School Diploma with 5+ years relevant experience + Working knowledge of GCP, ICH guidelines, and general clinical research operations. + Strong attention to detail and commitment to data accuracy and compliance. + Excellent communication, documentation, and organizational skills. + Ability to establish and maintain effective working relationships with coworkers, managers and clients + Ability to work independently and collaboratively across sites and teams. + Proficient in technology, including Microsoft Office suite and SharePoint + Ability to think critically and analyze study and site context to anticipate risk. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $54,200.00 - $135,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

Created: 2026-04-03