Clinical Research Associate

1 semana atrás

Brasil ENGINEERINGUK Tempo inteiro
Clinical Research Associate - Accelerated Research

As a Clinical Research Associate, you will play a crucial role in accelerating drug/device/outcomes research by ensuring patient safety and data integrity through independent monitoring of studies.

You will be part of a program that takes a collaborative approach to co-monitoring, enabling a supportive and open work environment. Regular communication with both internal teams and clients ensures alignment on shared goals.

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.
  • 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 delivery.
  • Verify proper management and accountability of Investigational Product (IP).
  • Write and submit reports of investigational site findings and update 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.
  • Participate in audit preparation and follow-up activities as needed.
  • Independently perform various onsite and offsite monitoring visit types.
  • Gather and review information for assigned sites and identify inconsistencies.
  • Assess risk and escalate as necessary.
  • Assist with non-complex ad-hoc, short-term assignments in support of additional studies or departmental initiatives.
  • May serve as a preceptor, providing training to less experienced clinical team members.

Requirements:

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

What ICON Offers:

At ICON, we value diversity, inclusion, and belonging. Our diverse workforce makes us more innovative, allowing us to better serve our people, patients, customers, and communities. We're proud of our inclusive organization and the work we've done to become a more welcoming place for everyone.

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