Specialist, Research Quality Assurance - FT - days
Core
Ensures clinical research activities comply with federal regulations, institutional policies, and ethical standards through quality oversight, audits, and monitoring.
Role type
Research Quality Assurance Specialist
Builds
Compliant clinical research programs and high-quality documentation
Domain
Healthcare / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research regulations (ICH GCP, FDA CFR, HIPAA), Informed Consent review, Source data verification, Audit execution, Risk assessment, Root cause analysis, Training development, CAPA management
Preferred skills
Oncology/Hematology research experience, SOCR/ACRP certification, Epic/REDCap knowledge, NCI CTSU familiarity
Technologies
Epic, REDCap, Complion
Responsibilities
Develop and deliver training materials for research personnel; Review Informed Consent and Assent Forms for compliance; Conduct project-specific audits and source data verification; Generate monitoring reports and manage corrective actions; Support risk assessments and continuous quality improvement initiatives.
Seniority
Mid-level, hands-on IC