Clinical Research Associate, Mid-level

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

📋 Description

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

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

• Conduct thorough assessments of site performance and assist in implementing corrective and preventive measures.

• Work alongside the Project Manager to establish, review, and track the monitoring plan.

• Evaluate monitoring reports from less experienced CRAs to ensure consistency and quality standards.

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

• Recognize operational risks and suggest strategies for mitigation to maintain timelines, data integrity, and participant safety.

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

• Assist with additional study activities, including eTMF review, regulatory support, and coordination with the sponsor on operational deliverables.

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

⛳️ Requirements

• Bachelor’s degree in a health-related field.

• Proficient in English.

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

• Experience as a CRA, preferably with a background in multicenter and international studies.

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

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

🏝️ Benefits

• Transportation voucher

• Parking (subject to availability)

• Health plan with no monthly premium for the employee; copayment for exams and consultations

• Dental plan with employee copayment

• Life insurance at no cost to the employee

• Flexible meal/food allowance

• Pharmacy benefits

• Synvia Partnership Club (educational institutions, language schools, leisure and culture)

• Partnership with SESC

• Physical wellness program – TotalPass

• Day off — Health Professional

• Childcare assistance (according to internal policy)