Clinical Research Monitor

A company is looking for a Clinical Research Monitor (Remote).

Key Responsibilities :

Design and implement risk-based quality management frameworks and centralized monitoring processes for clinical programs

Review study protocols to ensure feasibility of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)

Analyze clinical data to identify site performance issues and provide recommendations to study teams

Qualifications :

3+ years of experience in centralized monitoring within a CRO or clinical research setting

Prior experience as a CRA or in an equivalent monitoring role

Experience with infectious disease or oncology clinical research studies

Strong knowledge of ICH-GCP, FDA regulations, and risk-based monitoring principles

Bachelor's degree in life sciences or a related field; advanced degree preferred