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, regulatory authorities, and internal functional teams across multiple therapy areas.
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
Fluent in local languages and English
Nice-to-have
Subject matter expert for monitoring processes
Root cause analysis and corrective actions
Mentoring and knowledge sharing capabilities
Solution-oriented problem solving skills
Culturally sensitive working relationships
Key Requirements
Associate's degree plus 5 years healthcare experience
Bachelor's degree plus 2 years monitoring experience
Direct site management experience in bio/pharma/CRO
Valid driving license required
Hands-on knowledge of Good Documentation Practices