Cra 2, Brazil PCD

IQVIA; São Paulo; Presencial; BRL 108 000 - 180 000; Tempo integral

Resumo da oferta

IQVIA Biotech is seeking a Clinical Research Associate (CRA) 2 to join our team for on-site monitoring in oncology. The role requires at least 1 year of on-site monitoring experience and a strong grasp of GCP and ICH guidelines.

You will conduct site visits, train site staff, manage patient enrollment plans, and ensure regulatory compliance. Travel is expected as required by the project, and the position emphasizes data integrity and collaboration with cross-functional teams.

Qualificações

• Bachelor’s degree in life sciences or health-related field or equivalent experience.
• At least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.

Responsabilidades

• Conduct all site visits—selection, initiation, monitoring, and close-out per scope, GCP, and ICH.
• Collaborate with site staff on recruitment strategies aligned with timelines and enrollment goals.
• Deliver protocol training to site personnel and maintain clear communication to manage expectations.

Conhecimentos

GCP knowledge

ICH guidelines

Travel readiness

Regulatory compliance

On-site monitoring experience

Formação académica

Bachelor’s degree in life sciences or health-related field

Ferramentas

TMF/ISF documentation

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. .

Vaga Exclusiva para Pessoa com deficiência (PCD)