Site Monitor II - FSP

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Site Monitor II – FSP based in Brazil.

This role is essential to ensuring the integrity, quality, and compliance of clinical trial data across assigned study sites within global research programs.
You will act as the primary point of contact for investigative sites, supporting them throughout the study lifecycle from initiation to close-out.
The position combines on-site and remote monitoring activities, with a strong focus on data quality, protocol adherence, and regulatory compliance under ICH-GCP standards.
You will build strong, collaborative relationships with site staff while proactively identifying and resolving operational and compliance issues.
A key part of the role is ensuring sites remain inspection-ready through continuous oversight, documentation review, and training support.
You will also contribute to study performance tracking, recruitment support, and issue escalation when required.
This is a dynamic field-based role where scientific rigor, communication, and attention to detail directly safeguard patient safety and study success.

Accountabilities:

• 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.
• Build and maintain strong relationships with investigators and site staff, providing ongoing support, training, and issue resolution.
• Evaluate site performance, recruitment progress, and compliance, recommending corrective and preventive actions where needed.
• Identify, document, and resolve data integrity, protocol deviation, and operational issues in collaboration with site teams.
• 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.
• Participate in investigator meetings, audits, and regulatory inspections as required.

Requirements:

• Minimum 3 years of experience as a Clinical Research Monitor (CRA), with experience in both onsite and/or remote monitoring.
• Degree in biological sciences, pharmacy, nursing, or a related health/science discipline preferred.
• Strong understanding of ICH-GCP guidelines, clinical trial processes, and regulatory compliance requirements.
• Experience working with CTMS, EDC, IVRS, and electronic document management systems.
• Strong problem-solving and analytical skills with the ability to manage complex site-level issues independently.
• Excellent communication and interpersonal skills, with the ability to build effective relationships in a global environment.
• Ability to manage multiple priorities, meet tight timelines, and work effectively in a matrix organization.
• Fluency in English required; additional local language proficiency is an advantage.
• Willingness to travel extensively as required by study needs.

Benefits:

• Competitive compensation aligned with clinical monitoring experience
• Opportunity to work on global, multi-country clinical trials
• Flexible work model with a mix of remote and onsite monitoring activities
• Career development in clinical operations and study oversight
• Exposure to international regulatory environments and inspection processes
• Collaborative global team environment
• Continuous learning in advanced clinical trial technologies and systems

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1