Senior Clinical Research Monitor

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Act as the technical authority for the project, aiding in the planning and execution of monitoring strategies;

• Oversee monitoring of complex sites, high-recruiting locations, or those with a history of significant deviations;

• Conduct thorough evaluations of site performance and assist in the development of corrective and preventive measures;

• Work alongside the Project Manager to define, review, and monitor the monitoring plan;

• Assess monitoring reports from less experienced CRAs, ensuring consistency and quality;

• Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA) by offering technical guidance;

• Identify operational risks and suggest mitigation strategies to guarantee compliance with timelines, data integrity, and participant safety;

• Facilitate technical training sessions, initiation visits, and internal training for new CRAs;

• Assist with additional study activities, such as eTMF reviews, regulatory support, and alignment with the sponsor on operational deliverables;

• Maintain senior-level communication with both internal and external stakeholders, representing the monitoring function when necessary.

⛳️ Requirements

• Bachelor's degree in a health-related field (Pharmacy, Biomedicine, Nursing, or similar disciplines);

• Understanding of ICH-GCP and relevant regulations;

• Some preliminary experience or practical knowledge in clinical monitoring (on-site or remote);

• Familiarity with clinical systems (eCRF, CTMS, eTMF) is advantageous;

• Experience in Bioequivalence, PK/PD, or Phase I studies is preferred;

• Intermediate proficiency in English (reading and writing; conversational skills are a plus).

🏝️ Benefits

• Transportation allowance (commuter benefit);

• Parking (subject to availability);

• Health insurance with no monthly premium for the employee, including co-payments for exams and consultations;

• Dental plan with employee co-payment;

• Life insurance provided at no cost to the employee;

• Flexible meal/food allowance;

• SESC partnership;

• Physical wellness program – TotalPass;

• Day off for health professionals;

• Childcare assistance (according to internal policy).