CRA (Level II)
Core
Coordinate clinical monitoring and site management activities across assigned studies and investigative sites to ensure trials follow approved protocols and regulatory requirements.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trials for pharmaceutical and biotechnology studies
Domain
Clinical research / Life sciences
Required skills
Risk-based monitoring, source data verification, root-cause analysis, ICH-GCP compliance, site initiation and close-out, clinical trial management systems, medical/therapeutic terminology, travel management
Preferred skills
Registered Nursing certification, experience with biological fluids/infectious organisms, flexible adaptability
Technologies
Clinical trial management systems, Microsoft Office
Responsibilities
Conduct remote and on-site monitoring visits assessing protocol compliance and data quality; Perform source data review, verification, CRF review, and essential document checks; Identify site deficiencies and recommend corrective and preventive actions; Maintain regular communication with investigative sites; Initiate clinical trial sites and support site close-out activities; Ensure essential documents are complete and maintained; Provide study status updates in clinical trial management systems; Complete administrative activities including expense reports and timesheets.