CRA II or Sr CRA (sponsor dedicated) - Min 3 years of previous monitoring exp - CDMX
Core
Conduct clinical site monitoring, qualification, and management to ensure regulatory compliance and data integrity for biopharmaceutical studies.
Role type
Senior Clinical Research Associate (CRA) / Site Management Associate
Builds
Clinical trial data and patient safety outcomes
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site qualification and initiation, Source Document Review, Case Report Form (CRF) verification, Investigational Product (IP) management, Protocol compliance monitoring, Audit preparation, Query resolution, Site recruitment support
Preferred skills
Real World Late Phase study design knowledge, Chart abstraction, Local market knowledge for site identification
Technologies
Electronic Data Capture (EDC) systems, Tracking systems, Clinical Monitoring/Site Management Plans (CMP/SMP)
Responsibilities
Perform site qualification, initiation, interim monitoring, and close-out visits; Verify informed consent processes and patient safety; Conduct Source Document Reviews and ensure CRF accuracy; Manage Investigational Product inventory and administration; Review Investigator Site Files (ISF) and ensure archiving compliance; Support subject recruitment and retention; Prepare for and attend investigator and sponsor meetings; Provide guidance on audit readiness.
Seniority
Mid-Senior level, hands-on IC