Clinical Research Associate, IQVIA Biotech

BZL IQVIA RDS Brasil Ltda; São Paulo; Presencial; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

A leading global clinical research organization is seeking a Clinical Research Associate (CRA 2) for their São Paulo office. The ideal candidate will have a minimum of 1 year of on-site monitoring experience in oncology. Responsibilities include conducting site visits, collaborating on recruitment strategies, delivering training, assessing site performance, and ensuring compliance with study protocols and regulatory requirements. This role offers an opportunity to contribute significantly to clinical research data integrity and quality.

Qualificações

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

Responsabilidades

• Conduct site visits for selection, initiation, monitoring, and close-out.
• Collaborate with site staff on subject recruitment strategies.
• Deliver protocol training and maintain communication with site personnel.
• Assess site performance and escalate quality concerns.
• Monitor study progress and track regulatory submissions.
• Ensure maintenance of essential documents in TMF and ISF.
• Document site management activities and visit outcomes.
• Support study execution with project teams.
• Support site-level recruitment planning and financial management.

Descrição da oferta de emprego

IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring in oncology.

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview

We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

• Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.

• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.

• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.

• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.

• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.

• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.

• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.

• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.

• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).

• Requires at least 1 year of on-site monitoring experience.

• Strong understanding of GCP, ICH guidelines, and regulatory requirements.

• Ability to travel as required by the project.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com