As a Lead Clinical Research Associate, you will provide leadership, oversight, and mentorship to clinical study teams at a country or regional level. This role focuses on high-quality execution, compliance, and consistency in monitoring practices with minimal direct site management.
Key Responsibilities
Monitor project timelines, patient enrollment, and data integrity.
Review monitoring visit reports and ensure regulatory compliance.
Act as the primary communication bridge between monitors, site management, and project leads.
Lead project team calls and provide status updates to stakeholders.
Supervise source data verification and risk management at the site level.
Coordinate clinical supply management and essential study document reconciliation.
Oversee CAPA development and implementation.
Mentor and train newly promoted Lead CRAs and clinical staff.
Requirements
Educational background in Life Sciences (MD, MPharm, RN, or equivalent).
Minimum 4 years of site monitoring experience in general clinical projects.
Experience with Phase II/III monitoring and site management in the US.
Strong proficiency in Oncology, Cell/Gene Therapy, or GI preferred.
Full working proficiency in English and MS Office applications.
📌 Lead Clinical Research Associate (Santiago)
🏢 Hunt Remotely
📍 Santiago
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