Clinical Research Systems Quality Specialist, Fully

Overview 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. 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. Our vision is to provide the best Rheumatology care, anywhere and to balance sustainable operation with the highest possible level of patient care. We are seeking an ambitious, friendly, positive, and compassionate Clinical Research Systems Quality Specialist to join our team.

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

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

Experienced 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

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