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 subject safety and data integrity.
Candidates must possess strong communication skills to collaborate with investigators, vendors, and internal functional areas while maintaining high quality and compliance standards.
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 data accuracy
Adverse event reporting requirements
Root cause analysis and corrective actions
Nice-to-have
Subject Matter Expertise in monitoring processes
Strong interpersonal and conflict management skills
Ability to work independently in matrix environment
Growth mindset and solution-oriented approach
Experience with audit/inspection support
Key Requirements
Associate's degree in scientific/healthcare discipline with 5 years experience
Bachelor's degree with 2 years direct site management experience
Fluent in local languages and English
Valid driving license required
Hands-on knowledge of Good Documentation Practices