CRA II, Clinical Research Associate

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

📋 Description

• Conduct qualification, initiation, routine monitoring, and close-out visits independently at sites with higher complexity.

• Carry out source data verification and review documentation to guarantee integrity, accuracy, and consistency.

• Oversee adverse events and collaborate with the safety/pharmacovigilance team when necessary.

• Examine site regulatory documentation to ensure continuous compliance with the protocol and relevant regulatory requirements.

• Aid in addressing operational challenges and study deviations in partnership with the Project Manager.

• Provide support to underperforming sites by following up on corrective and preventive actions; report and manage protocol deviations.

• Educate site teams on study-related subjects, tools, and operational processes.

• Help train and co-monitor junior Clinical Research Associates (CRAs).

• Maintain open and ongoing communication with stakeholders, internal teams, and sponsors.

⛳️ Requirements

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

• Comprehensive understanding of Good Clinical Practice (GCP) and demonstrated experience in monitoring activities (PSV, SIV, RMV, COV).

• Proficiency in English at an intermediate to advanced level.

• Previous experience working as a Clinical Research Associate (CRA).

• Familiarity with eClinical systems (eTMF, CTMS, EDC).

🏝️ Benefits

• Transportation allowance (Vale Transporte).

• Parking available (subject to availability).

• Health insurance with no monthly premium for the employee, with co-pay for examinations 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 (offers educational institutions, language schools, and leisure and cultural benefits).

• Partnership with SESC.

• Physical health program - TotalPass.

• Day Off for healthcare professionals.

• Childcare assistance provided (as per internal policy).