CRA 2, Brazil

IQVIA; São Paulo; Presencial; BRL 100 000 - 145 000; Tempo integral

Resumo da oferta

IQVIA Biotech is hiring a Clinical Research Associate (CRA) II for on-site monitoring in oncology at our São Paulo site. You will monitor trial sites to ensure protocol adherence, GCP compliance, and data integrity, coordinating with site staff and cross-functional teams.

The role requires at least 1 year of on-site monitoring experience, travel as needed, and a life sciences degree. IQVIA Biotech offers a collaborative environment with exposure to cutting-edge oncology trials.

Qualificações

• Bachelor's degree in life sciences or related field.
• 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 (selection, initiation, monitoring, close-out) per GCP/ICH.
• Support subject recruitment strategies to meet enrollment goals.
• Provide protocol training to site personnel and maintain communication to resolve issues.
• Monitor site performance and data integrity, escalate issues as needed.
• Track regulatory submissions, enrollment, CRF completion, and data queries.
• Maintain TMF and ISF documentation per regulatory standards.
• Document site activities and follow-up actions in reports and emails.
• Collaborate with cross-functional teams to support study execution and goals.
• Assist with site recruitment planning and budget tracking where required.

Conhecimentos

GCP knowledge

ICH guidelines

Regulatory compliance

Formação académica

Bachelor’s degree in life sciences

Ferramentas

TMF 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

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.