Clinical Research Systems Quality Specialist

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    "html_title": "ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES - Clinical Research Systems Quality Specialist",
    "description_html": "<p>Our providers work together to keep patients healthy and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.</p><p>We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.</p><p>Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.</p><p>We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Systems Quality Specialist to join our team.</p><p>Under minimal supervision, the System Quality Specialist (SQS) owns and improves the quality, integrity, and compliance readiness of clinical research electronic systems (e.g., CTMS, eSource/EDC, eRegulatory, M365, and related reporting tools). The SQS defines data quality standards and controls, manages system change control and quality validation/testing, monitors system performance using dashboards and metrics, and maintains audit-ready documentation (SOPs, training records, configuration and validation evidence). The SQS partners with cross-functional stakeholders to implement study builds and amendments, communicate system updates, ensure appropriate access controls, and drive corrective/preventive actions to prevent recurring system and data quality issues.</p><p><br></p><p>RESPONSIBILITIES</p><ul><li>Establish and maintain system quality management practices for clinical research platforms (e.g., CTMS, eSource/EDC, eRegulatory, M365), including documentation standards, validation evidence, and release readiness criteria</li><li>Ensure architecture and data inputs for systems below continuously meet or exceed minimum quality standards</li><li>Clinical Conductor CTMS</li><li>Advarra eSource +EDC</li><li>Veeva SiteVault eReg</li><li>Monday Work Management</li><li>SharePoint Pages &amp; Training Workflows</li><li>Power Query/BI Dashboards</li><li>in the CTMS system for both protocol and financial compliance</li><li>Review, finalize and approve esource and CTMs builds for all new studies and amendments</li><li>Ensure all systems are updated when amendments occur and announce changes to stakeholders</li><li>Perform routine quality inspections of system data inputs for compliance with internal policy, standard operating procedures, ICH-GCP Standards, local and FDA regulations</li><li>Ensure all system quality controls are in place prior to release (e.g., procedural instructions, conditional/required fields, data constraints, standardized build templates, and controlled vocabularies) to reduce downstream queries and protocol deviations</li><li>Perform root cause analysis for recurring system/data quality issues; lead remediation plans to prevent reoccurrence (process, training, configuration, or automation changes)</li><li>Maintain dashboards/metrics (e.g., query rates, missing/late data, build defect rates, timeliness KPIs) and drive corrective/preventive actions</li></ul><p><br></p><p>Learn more about AARA on our website at http://azarthritis.com</p>",
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      "datePosted": "2026-05-05T20:12:20-05:00",
      "description": "<p>Description</p><p>Our providers work together to keep patients healthy and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.</p><p>We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.</p><p>Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.</p><p>We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Systems Quality Specialist to join our team.</p><p>Under minimal supervision, the System Quality Specialist (SQS) owns and improves the quality, integrity, and compliance readiness of clinical research electronic systems (e.g., CTMS, eSource/EDC, eRegulatory, M365, and related reporting tools). The SQS defines data quality standards and controls, manages system change control and quality validation/testing, monitors system performance using dashboards and metrics, and maintains audit-ready documentation (SOPs, training records, configuration and validation evidence). The SQS partners with cross-functional stakeholders to implement study builds and amendments, communicate system updates, ensure appropriate access controls, and drive corrective/preventive actions to prevent recurring system and data quality issues.</p><p><br/></p><p>RESPONSIBILITIES</p><ul><li>Establish and maintain system quality management practices for clinical research platforms (e.g., CTMS, eSource/EDC, eRegulatory, M365), including documentation standards, validation evidence, and release readiness criteria</li><li>Ensure architecture and data inputs for systems below continuously meet or exceed minimum quality standards</li><li>Clinical Conductor CTMS</li><li>Advarra eSource +EDC</li><li>Veeva SiteVault eReg</li><li>Monday Work Management</li><li>SharePoint Pages & Training Workflows</li><li>Power Query/BI Dashboards</li><li>in the CTMS system for both protocol and financial compliance</li><li>Review, finalize and approve esource and CTMs builds for all new studies and amendments</li><li>Ensure all systems are updated when amendments occur and announce changes to stakeholders</li><li>Perform routine quality inspections of system data inputs for compliance with internal policy, standard operating procedures, ICH-GCP Standards, local and FDA regulations</li><li>Ensure all system quality controls are in place prior to release (e.g., procedural instructions, conditional/required fields, data constraints, standardized build templates, and controlled vocabularies) to reduce downstream queries and protocol deviations</li><li>Perform root cause analysis for recurring system/data quality issues; lead remediation plans to prevent reoccurrence (process, training, configuration, or automation changes)</li><li>Maintain dashboards/metrics (e.g., query rates, missing/late data, build defect rates, timeliness KPIs) and drive corrective/preventive actions</li></ul><p><br/></p><p>Learn more about AARA on our website at http://azarthritis.com</p><p>Requirements</p><p>QUALIFICATIONS</p><ul><li>Bachelor’s Degree or equivalent</li><li>2 years clinical research coordinator experience </li><li>Rheumatology Experience Preferred</li><li>Must be able to sit for long periods of time</li><li>Demonstrated experience applying quality controls to electronic clinical research systems to ensure accurate, complete, and timely data</li><li>Expensive working knowledge of relevant electronic systems, including eSource, CTMS, eReg, and Microsoft 365 </li><li>Strong understanding of good clinical practice, FDA regulations, & data integrity principles (e.g., ALCOA/C+) with an ability to translate them into system configuration, workflows, and user guidance</li><li>Proficiency building and interpreting operational quality metrics and dashboards</li></ul>",
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