Site Monitor II - FSP Brazil Operations – Project Management

Primary Responsibilities:

• Act as the primary contact for assigned study sites, ensuring proper implementation of protocols and compliance with ICH-GCP and local regulatory requirements.
• Conduct on-site and remote monitoring visits, including qualification, initiation, interim, and close-out visits, while generating accurate visit reports.

Collaboration and Compliance:

• Build and maintain strong relationships with investigators and site staff, providing ongoing support, training, and issue resolution.
• Identify, document, and resolve data integrity, protocol deviation, and operational issues in collaboration with site teams.

Data and Documentation Management:

• Ensure timely follow-up on CRFs, queries, SAEs, and study documentation within CTMS, EDC, and TMF systems.
• Maintain inspection readiness of sites and ensure proper management of study supplies, IP accountability, and regulatory documentation.