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 cross-functional teams including regulatory affairs, pharmacovigilance, and legal departments.
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
Adverse event reporting requirements
Protocol adherence and data accuracy
Root cause analysis and corrective actions
CTMS and eTMF system proficiency
Nice-to-have
Subject Matter Expertise in monitoring processes
Mentoring and buddy responsibilities
Audit and inspection support experience
Solution-oriented problem solving
Culturally sensitive working relationships
Growth mindset and self-driven approach
Key Requirements
Associate's degree or Bachelor's in scientific/healthcare discipline
At least 2 years direct site management (monitoring) experience
Fluent in Local Languages and English
Valid driving license required
Hands-on knowledge of Good Documentation Practices