The role is accountable for performance and compliance for assigned protocols and sites in a country under the oversight of the CRA-Manager
Job Summary
The role is accountable for performance and compliance for assigned protocols and sites in a country under the oversight of the CRA-Manager.
The incumbent acts as the primary site contact and manager throughout all phases of a clinical research study, ensuring data accuracy and subject safety.
Candidates must possess at least 2 years of direct site management experience in a bio/pharma/CRO setting or 5 years of healthcare experience with 2 years in monitoring.
Matching Summary
The role is accountable for performance and compliance for assigned protocols and sites in a country under the oversight of the CRA-Manager.
Skills & Requirements
Must-have
ICH-GCP and country regulations compliance
Site management and monitoring activities
Protocol adherence and adverse event reporting
Fluent in local languages and English
Hands-on knowledge of Good Documentation Practices
Experience with CTMS and eTMF systems
Nice-to-have
Subject Matter Expertise in monitoring processes
Root cause analysis and corrective action skills
Ability to work in a matrix multicultural environment
Strong interpersonal and conflict management skills
Growth mindset and self-driven approach
Key Requirements
Associate's degree plus 5 years healthcare experience including 2 years monitoring
Bachelor's degree plus 2 years direct site management experience