Clinical Research Quality Assurance Monitor III

Summary

This role is responsible for overseeing the quality assurance of cooperative group- industry-sponsored and investigator-initiated clinical studies. This role ensures that all processes contributing to clinical study performance are conducted in accordance with study protocols applicable regulatory requirements Good Clinical Practice (GCP) and institutional standard operating procedures (SOPs). The QA Monitor Level III conducts routine and ongoing internal monitoring participates in external audits and travels for regular site visits to ensure compliance and quality in clinical research operations.

Job Responsibilities

Perform routine and ongoing internal clinical study monitoring to ensure adherence to protocols regulatory requirements GCP and institutional SOPs.
Conduct regular site visits including onboarding new research staff verifying participant eligibility performing timely research chart reviews and executing source data verification.
Review training records to confirm that research staff and sites maintain compliance with required training curricula.
Provide project-specific compliance support including review of study protocol requirements GCP/compliance inquiries essential document development/review Corrective and Preventive Action (CAPA) plan development and audit/inspection support.
Work closely with study investigators and research teams throughout the monitoring and auditing process offering guidance and real-time education when significant concerns or issues are identified.
Meet with investigators and research teams to review monitoring findings and develop CAPA plans as needed.
Assist clinical research staff in preparing and verifying responses to queries generated from study protocol monitoring.
Collaborate with QA Leadership to draft monthly and quarterly summary reports.
Discuss potential workflow improvements evaluate verification procedures and implement quality assurance and risk assessment/reduction strategies to ensure research compliance.
Contribute to the development and refinement of research quality assurance processes.
Perform other duties as assigned to support the organizations clinical research objectives.

Requirements

Experience

Minimum: 4 years of clinical research experience in a clinical research organization research site pharmaceutical/device industry or site management organization preferably with some Oncology focus (other areas acceptable). Intermediate skills in medical/research chart review investigator site file review and using EMR EDC Excel Word and PowerPoint.

Education

Minimum: Masters degree preferably in Science or a Health-related field.

Skills

Minimum: Able to manage competing and shifting priorities. Knowledge of medical terminology.
Intermediate knowledge of FDA- regulated research ICH Guidelines and GCP. Detail oriented highly organized and able to think critically and problem solve. Strong interpersonal and writing skills. Ability and availability to travel to Metro area sites and Tri-State area sites (TN MS AR) and travel for training. Some overnight stay may be required.

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