Sr clinical research associate – São Paulo/SP [remoto]

Responsabilidades

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff.
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
• Verification that the investigator is enrolling only eligible subjects.
• Regulatory document review.
• Investigational product/drug accountability and inventory.
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Requisitos

• Bachelor’s degree in a health or science related field is required.
• 5+ years of experience in clinical monitoring or CRC experience preferred.
• Willingness to travel nationwide within Brazil.
• Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF and reconciling TMF documentation.
• Excellent verbal and written communication skills in Portuguese and English.

Benefícios

• Dynamic working environment, with varying responsibilities day-to-day.
• Expansive experience in multiple therapeutic areas.
• Work within a team of therapeutic and regulatory experts.
• Defined CRA promotion and growth ladder with potential for mentoring and management advancements.
• Competitive pay and opportunity for significant travel bonus.
• Competitive compensation programs that recognize and reward performance.
• Comprehensive health, wellness, retirement, and PTO benefits.
• Office based culture with occasional WFH that provides flexibility for eligible positions after training.
• Company-sponsored social events.

Marcado como: Assuntos Regulatórios, Dispositivos Médicos, Farmacovigilância, Indústria Farmacêutica, Pesquisa Clínica