Clinical Research Associate I

1 semana atrás

Brasília, Distrito Federal, Brasil Engineeringuk Tempo inteiro
Clinical Research Associate I Job Description

Clinical Research Associates play a vital role in accelerating drug/device/outcomes research by ensuring patient safety and data integrity through independent monitoring of studies. Our program takes a collaborative approach, fostering a supportive work environment through frequent and consistent communication with clients.

Key Responsibilities:
  • Conduct onsite 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 to applicable regulations.
  • 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 to applicable tracking systems.
  • Escalate observed deficiencies, issues, and corrective and preventative action plans as necessary.
  • 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, including key risk indicator and site health analysis, site process evaluation, and project escalation.
  • Participate in audit preparation and follow-up activities as needed.
  • Independently perform various onsite and offsite monitoring visit types.
Requirements:
  • Undergraduate degree or international equivalent in a 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 required 50-80%.
What ICON Offers:

At ICON, we value diversity, inclusion, and belonging. Our diverse workforce enables us to better serve our people, patients, customers, and communities. We offer a range of benefits, including a competitive salary, to support your well-being and work-life balance. Join our team and contribute to accelerated drug/device/outcomes research.

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