Lead Oncology Trials Specialist

Bebeeclinicalresearch; Salvador; Presencial; BRL 60.000 - 80.000; Tempo integral

Resumo da oferta

A clinical research organization in Salvador, Brazil, seeks a Clinical Research Associate to oversee operational aspects of clinical trials. The role involves site qualification, regulatory compliance, and data management, ensuring adherence to protocols. Candidates must have a Bachelor's degree in life sciences and 2-4 years of oncology trial experience. Strong knowledge of Good Clinical Practice and FDA regulations is essential. This position offers an opportunity to impact important clinical research efforts.

Qualificações

• Minimum 2-4 years experience as a Clinical Research Associate in oncology trials.
• Strong knowledge of Good Clinical Practice (GCP) and FDA regulations.
• Familiarity with EDC systems and clinical trial management systems.

Responsabilidades

• Conduct thorough site assessments including qualification, initiation, and monitoring.
• Maintain clinical trial documentation according to regulatory standards.
• Identify and report adverse events and ensure accurate data documentation.

Conhecimentos

Site management

Regulatory compliance

Data management

Good Clinical Practice (GCP)

FDA regulations

Formação académica

Bachelor's degree in life sciences or related field

Ferramentas

Electronic data capture (EDC) systems

Clinical trial management systems (CTMS)

Descrição da oferta de emprego

Contract Clinical Research Associate

To excel in this role, you will be responsible for overseeing the operational aspects of clinical trials. Your expertise will be critical in ensuring that trial sites adhere to established protocols and regulatory guidelines.

Key Responsibilities

• Site Qualification and Management: Conduct thorough site assessments, including qualification, initiation, monitoring, and close-out visits. Verify compliance with regulatory requirements and ensure accurate data collection and reporting. Monitor site performance and implement corrective actions as needed.
• Regulatory Compliance: Maintain all clinical trial documentation according to regulatory standards. Review informed consent documents and confirm proper consenting procedures are in place. Collaborate with regulatory teams to facilitate timely submissions and approvals.
• Safety and Data Management: Identify and report adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities. Validate source data and resolve discrepancies. Ensure accurate and timely documentation of clinical trial data in electronic data capture (EDC) systems.

Qualifications

• Bachelor's degree in a life science or related field.
• A minimum of 2-4 years of experience as a Clinical Research Associate in oncology trials, preferably with Phase 2 experience.
• Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).