Lead Clinical Research Associate

Key Responsibilities:

• Monitors project timelines, patient enrollment, and data cleaning, implementing corrective measures as needed.
• Reviews monitoring visit reports and ensures reporting compliance, acting as the main communication line between project teams.
• Supervises source data verification, manages study risks, and ensures proper handling of investigational products.

Leadership and Coordination:

• Leads project team calls and provides status updates to regional leads and project managers.
• Delivers project-specific training and prepares training materials for the team under supervision.
• Coordinates safety information flow, protocol deviation reporting, and clinical supplies management with vendors.

Quality and Compliance Oversight:

• Ensures data integrity and compliance at site and country levels, reviewing essential study documents.
• Conducts site audit preparation visits and participates in audits, coordinating resolution of findings.
• Oversees CAPA development and implementation, and manages the query resolution process for monitors.