Clinical Research Associate I
Há 6 dias
Job Summary:
Clinical Research Associate I is a key role in our organization, responsible for ensuring the integrity of clinical data and compliance with approved protocol, GCP, and applicable regulations. The successful candidate will have a strong background in clinical trials, excellent communication skills, and the ability to work independently.
Key Responsibilities:
- Completes onsite and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
- Verifies the protection of study participants by confirming informed consent procedures and protocol adherence.
- Ensures the integrity of clinical data and compliance with approved protocol, GCP, and applicable regulations.
- Manages investigative site staff to facilitate trial deliverables, such as subject enrollment and data deliverables.
- Verifies proper management and accountability of Investigational Product (IP).
- Writes and submits reports of investigational site findings and updates applicable tracking systems.
- Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Manages essential documents as required by local regulations and ICH-GCP guidelines.
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%.
What We Offer:
At ICON, we value diversity, inclusion, and belonging. We offer a competitive salary, a range of benefits, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.
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