Specialist, Research Quality Assurance - FT - Days - MHS
Core
Ensures clinical research activities comply with federal regulations, institutional policies, and ethical standards through audits, monitoring, and training.
Role type
Research Quality Assurance Specialist
Builds
Compliant clinical research programs and training materials
Domain
Healthcare / Clinical Research
Required skills
Clinical research regulations (ICH GCP, FDA CFR, HIPAA), Source data verification, Audit and monitoring, Corrective and preventive actions (CAPA), Training development and delivery, Informed consent review
Preferred skills
Oncology and/or Hematology research experience, Knowledge of Epic and REDCap, SOCRA or ACRP certification
Technologies
Epic, REDCap, Complion
Responsibilities
Conduct project-specific audits and monitoring for investigator protocols; Perform source data verification of research documentation; Generate monitoring reports and manage post-monitoring corrective actions; Develop and deliver training sessions for research personnel; Review Informed Consent and Assent Forms for compliance; Support risk assessments and continuous quality improvement initiatives.
Seniority
Mid-level, hands-on IC
