Regulatory Clinical Research Coordinator - Sarver Heart Center

• Preparation and submission of regulatory/IRB documents for sponsored and non-sponsored studies including but not limited to local IRB deferrals; local IRB full submissions; central IRB submissions; amendments; annual renewals; regulatory reportable items; and study closures.
• Maintain regulatory investigator site files and essential study documents in accordance with sponsor and institutional requirements. This includes collection of investigator qualifications, training records, financial disclosures, and required certifications. Track study approvals, expiration dates, investigator credentials, and required training.
• Preparation and submission of applications for institutional approvals including Research Administration Portal, Radiation Safety and Institutional Biosafety Committee for sponsored and non-sponsored studies including amendments. Maintain records for all studies in Oncore.
• Provide regulatory support for site initiation visits, monitoring visits, quality audits and close-out.
• Assist with updating and drafting department SOPs, study procedure manuals and regulatory workflows as required.

Knowledge, Skills & Abilities:

• Knowledge of FDA regulations, ICH-GCP, 45 CFR 46, HIPAA, and human subjects'' protection requirements.
• Knowledge of electronic IRB systems and clinical trial management systems (CTMS).