Clinical Research Associate
Há 6 dias
Clinical Research Associate Role Summary
At ENGINEERINGUK, we are seeking a highly skilled Clinical Research Associate to contribute to our accelerated drug/device/outcomes research program. As a Clinical Research Associate, you will play a critical role in ensuring patient safety and data integrity through independent monitoring of studies.
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 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 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.
Requirements:
- Undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution.
- Previous experience supporting clinical trials, including solid on-site monitoring experience.
- Based in São Paulo.
- Travel is required 50-80%.
What ICON Can Offer You:
At ENGINEERINGUK, we value diversity, inclusion, and belonging. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization.
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