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La logistique fluide, maîtrisée et sécurisée.
CRA II, Clinical Research Associate
Location
Brazil
Posted
114 days ago
Salary
0
Seniority
Mid Level
Job Description
CRA II, Clinical Research Associate
SYNVIA
• Independently conduct qualification, initiation, routine monitoring, and close-out visits at higher-complexity sites. • Perform source data verification and review documentation to ensure data integrity, accuracy, and consistency. • Monitor adverse events and collaborate with the study safety team when necessary. • Assess site regulatory documentation and ensure ongoing compliance with protocol requirements and regulatory authorities. • Assist in resolving operational issues and study deviations together with the Project Manager. • Support underperforming sites by tracking corrective and preventive actions; report and manage protocol deviations. • Train site teams on study-related topics, tools, and operational activities. • Assist in the training and co-monitoring of junior CRAs. • Maintain clear and continuous communication with stakeholders, internal teams, and sponsors.
Job Requirements
- Bachelor's degree (or higher) in a health-related field.
- Strong knowledge of GCP and proven experience in monitoring activities (Pre-Study Visit - PSV, Site Initiation Visit - SIV, Routine Monitoring Visit - RMV, Close-Out Visit - COV).
- Intermediate to advanced English.
- Previous experience as a CRA.
- Experience with eClinical systems (eTMF, CTMS, EDC).
Benefits
- Transportation allowance.
- Parking (subject to availability).
- Health insurance with no monthly premium for the employee; co-pay applies for tests and consultations.
- Dental plan with employee co-pay.
- Life insurance at no cost to the employee.
- Flexible meal/food allowance.
- Pharmacy benefits/discount program.
- Synvia Partnership Club (discounts with educational institutions, language schools, leisure and cultural services).
- SESC partnership benefits.
- Physical wellness program – TotalPass.
- Day Off – Health Professional.
- Childcare assistance (per internal policy).
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