Clinical Research Monitor – Mid-level

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 the monitoring of high-complexity sites, high-recruiting locations, or sites with a history of significant deviations.

• Carry out comprehensive evaluations of site performance and assist in the implementation of corrective and preventive actions (CAPAs).

• Work alongside the Project Manager to define, review, and monitor the progress of the monitoring plan.

• Assess monitoring reports from less experienced CRAs to ensure adherence to standards and quality.

• Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), offering technical support.

• Recognize operational risks and suggest mitigation strategies to guarantee compliance with timelines, data quality, and participant safety.

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

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

• Maintain communication at a senior level with both internal and external stakeholders, representing the monitoring function as required.

⛳️ Requirements

• Bachelor's degree in a health-related discipline.

• Proficient in English.

• Extensive knowledge of Good Clinical Practice (GCP), Brazilian and international regulations, along with experience in conducting and supporting audits.

• Background as a CRA, preferably with experience in multicenter and international studies.

• Demonstrated ability to serve as a technical reference and lead strategic study initiatives.

• Strong experience with eClinical systems (EDC, CTMS, eTMF).

🏝️ Benefits

• Transportation allowance (commuter benefit).

• Parking (subject to availability).

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

• Dental plan with employee co-pay.

• Life insurance at no cost to the employee.

• Flexible meal/food allowance.

• Pharmacy discount program.

• Synvia Partnership Club (discounts with educational institutions, language schools, leisure and cultural services).

• SESC partnership.

• Physical wellness program – TotalPass.

• Day Off for health professionals.

• Childcare assistance (subject to internal policy).