Clinical Research Monitor – Mid-level

Job not on LinkedIn

🕒 May 26

🗣️🇧🇷🇵🇹 Portuguese Required

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Logo of SYNVIA

SYNVIA

51 - 200 employees

Founded 1993

🚗 Transport

🤝 B2B

Transport • B2B

SYNVIA is a logistics and transport company specializing in secure, compliant, and customized supply chain solutions for high‑value and sensitive industries. The company provides multimodal transport (road, air, maritime), temperature‑controlled and regulated warehousing (including ICPE), handling of dangerous goods, customs transit services, and value‑added operations like co‑packing, labeling and kitting. SYNVIA focuses on B2B clients in sectors such as chemistry, energy, agriculture, cosmetics and public hygiene, emphasizing traceability, regulatory compliance, and operational agility.

📋 Description

• Serve as the technical reference for the project, supporting the planning and execution of monitoring strategies. • Conduct monitoring of high-complexity sites, high-recruiting sites, or sites with a history of critical deviations. • Perform in-depth assessments of site performance and support the implementation of corrective and preventive actions (CAPAs). • Collaborate with the Project Manager in defining, reviewing, and tracking the monitoring plan. • Review monitoring reports from less-experienced CRAs to ensure standardization and quality. • Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance. • Identify operational risks and propose mitigation strategies to ensure adherence to timelines, data quality, and participant safety. • Conduct technical training sessions, initiation visits, and internal training activities for new CRAs. • Support supplementary study activities such as eTMF review, regulatory support, and alignment with the sponsor on operational deliverables. • Maintain senior-level communication with internal and external stakeholders, representing the monitoring function as needed.

🎯 Requirements

• Bachelor's degree in a health-related field. • Advanced English. • Thorough knowledge of Good Clinical Practice (GCP), Brazilian and international regulations, and experience conducting and supporting audits. • Experience as a CRA, preferably with a background in multicenter and international studies. • Proven ability to act as a technical reference and lead strategic study activities. • 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).

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