Clinical Research Associate

2 semanas atrás

Brasil ENGINEERINGUK Tempo inteiro
Clinical Research Associate I Job Description

Job Summary:

We are seeking a highly motivated and detail-oriented Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will be responsible for conducting on-site and remote monitoring activities to ensure patient safety and data integrity.

Key Responsibilities:

  • Conduct on-site and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
  • Verify the protection of study participants by confirming informed consent procedures and protocol adherence.
  • Ensure the integrity of clinical data and compliance with approved protocol, GCP, applicable regulations, and SOPs.
  • Manage investigative site staff to facilitate trial deliverables, such as subject enrollment and data deliverables.
  • Verify proper management and accountability of Investigational Product (IP).
  • Write and submit reports of investigational site findings and updates applicable tracking systems.
  • Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
  • Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study.
  • Assist with resolution of investigational site/data queries.
  • Perform key risk assessment and management responsibilities throughout the project.
  • Participate in audit preparation and follow-up activities as needed.
  • Independently perform a variety of onsite and offsite monitoring visit types.
  • Gather and review information for assigned site and identify inconsistencies.
  • Assess risk and escalate as appropriate.

Requirements:

  • Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution.
  • Health care professional licensure, i.e., registered nurse.
  • Previous experience supporting clinical trials, including solid on-site monitoring experience.
  • Based in São Paulo.
  • Travel is required 50-80%.
  • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.

What We Offer:

At ICON, we value diversity, inclusion, and belonging. We offer a competitive salary, a range of additional benefits, and opportunities for professional growth and development. Our benefits are designed to support your well-being and work-life balance. We are committed to providing an inclusive and accessible environment for all candidates and employees.

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