Description

Description The Quality Monitoring Coordinator plans, coordinates and schedules the collection and analysis of research data samples to ensure all federal and state compliance monitoring requirements are met or exceeded. Responsibilities 1. Ensures compliance with good clinical practice and regulatory guidelines. 2. Completes and coordinates monitoring responsibilities in strict adherence to regulatory requirements, standards and protocols. 3. Monitors accurate, complete and timely data submission by clinical investigators and implements corrective action as necessary. 4. Evaluates research data, protocol compliance and research file organization for clinical trials. 5. Conducts assessments and monitors current clinical billing practices. 6. Communicates results from contact reports and monitoring visits to appropriate staff in a timely manner. 7. Assures adequate reporting of adverse events, protocol deviation and patient status. 8. Identifies areas requiring follow up and improvement at each clinical study site. Recommends corrective action as necessary. 9. Assures all study and regulatory documentation is properly maintained. 10. Assures adequate patient enrollment in study. 11. ...