Clinical Trials Quality & Compliance Lead

Mount Sinai Health System; New York (NY); On-site; USD 66,482 - 67,500; Full time

Job summary

Mount Sinai Health System seeks a Quality Monitoring Coordinator to lead data collection and analysis to ensure compliance with federal and state monitoring requirements. You will coordinate monitoring tasks, ensure timely data submission, and implement corrective actions as needed in clinical trials.

The role requires a science or health-related degree and several years of experience in regulatory-compliant monitoring.

Qualifications

• Bachelor's degree in Science or other health-related field.
• 3 years experience in a relevant role.

Responsibilities

• Ensures compliance with good clinical practice and regulatory guidelines.
• Completes and coordinates monitoring responsibilities in strict adherence to regulatory requirements, standards and protocols.
• Monitors accurate, complete and timely data submission by clinical investigators and implements corrective action as necessary.
• Evaluates research data, protocol compliance and research file organization for clinical trials.
• Conducts assessments and monitors current clinical billing practices.
• Communicates results from contact reports and monitoring visits to appropriate staff in a timely manner.
• Assures adequate reporting of adverse events, protocol deviation and patient status.
• Identifies areas requiring follow up and improvement at each clinical study site; recommends corrective action as necessary.
• Assures all study and regulatory documentation is properly maintained.
• Assures adequate patient enrollment in study.
• Develops programs and creates standard operating procedures to assure regulatory compliance in conduct of clinical research and billing for related procedures/services.
• Performs other related duties.

Education

Bachelor's degree in Science or health-related field

Job description

Mount Sinai Health System seeks a Quality Monitoring Coordinator to lead data collection and analysis to ensure compliance with federal and state monitoring requirements. You will coordinate monitoring tasks, ensure timely data submission, and implement corrective actions as needed in clinical trials.

The role requires a science or health-related degree and several years of experience in regulatory-compliant monitoring.