Regulatory Clinical Research Coordinator - Sarver Heart Center
University of Arizona
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- Location
- Tucson, United States
- Job type
- Full time
- Posted
- Oct 13
- 7 days ago
Career path
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About the company
University of Arizona
Higher education · 11 to 50 employees
What you'll do
- Prepare and submit regulatory and IRB documents, maintain investigator site files and study records, and track approvals, credentials, and training.
- Provide regulatory support for study visits and audits, and assist with department SOPs, procedure manuals, and workflows.
What you need
- Knowledge of FDA regulations, ICH-GCP, 45 CFR 46, HIPAA, human subjects' protection requirements, electronic IRB systems, and clinical trial management systems.
Key skills
FDA regulationsICH-GCP45 CFR 46HIPAAhuman subjects' protectionelectronic IRB systemsclinical trial management systems
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Read the full posting here
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).