We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Systems Quality Specialist to join our team.
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.
RESPONSIBILITIES
- 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
- Ensure architecture and data inputs for systems below continuously meet or exceed minimum quality standards
- Clinical Conductor CTMS
- Advarra eSource +EDC
- Veeva SiteVault eReg
- Monday Work Management
- SharePoint Pages & Training Workflows
- Power Query/BI Dashboards
- in the CTMS system for both protocol and financial compliance
- Review, finalize and approve esource and CTMs builds for all new studies and amendments
- Ensure all systems are updated when amendments occur and announce changes to stakeholders
- Perform routine quality inspections of system data inputs for compliance with internal policy, standard operating procedures, ICH-GCP Standards, local and FDA regulations
- 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
- Perform root cause analysis for recurring system/data quality issues; lead remediation plans to prevent reoccurrence (process, training, configuration, or automation changes)
- Maintain dashboards/metrics (e.g., query rates, missing/late data, build defect rates, timeliness KPIs) and drive corrective/preventive actions
Learn more about AARA on our website at http://azarthritis.com
Requirements
QUALIFICATIONS
- Bachelor's Degree or equivalent
- 2 years clinical research coordinator experience
- Rheumatology Experience Preferred
- Must be able to sit for long periods of time
- Demonstrated experience applying quality controls to electronic clinical research systems to ensure accurate, complete, and timely data
- Expensive working knowledge of relevant electronic systems, including eSource, CTMS, eReg, and Microsoft 365
- 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
- Proficiency building and interpreting operational quality metrics and dashboards
