Clinical Research Systems Quality Specialist

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
• Perform routine quality inspections of system data inputs for compliance with internal policy, standard operating procedures, ICH-GCP Standards, local and FDA regulations
• Maintain dashboards/metrics (e.g., query rates, missing/late data, build defect rates, timeliness KPIs) and drive corrective/preventive actions

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