Clinical Research Associate I – Remote/On‑site Monitoring
Thermo Fisher Scientific · Argentine
Description du poste
About the role
Join a global CRO team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Clinical Research Associate I you will conduct remote and on‑site monitoring visits, ensuring trials follow the approved protocol, ICH‑GCP guidelines and regulatory requirements.
Key responsibilities
- Perform risk‑based monitoring of investigator sites, applying root‑cause analysis and corrective actions.
- Verify data accuracy through source data verification (SDR), source data review (SDV) and case report form (CRF) checks.
- Assess investigational product inventory and documentation.
- Document observations in reports and letters, escalating deficiencies to clinical management.
- Maintain regular communication with sites to confirm protocol compliance and timely data entry.
- Participate in investigator payment processing and site initiation/close‑out activities.
- Support investigator meetings and assist in identifying qualified sites.
Required profile
- Strong understanding of clinical trial processes and regulatory standards.
- Ability to apply critical thinking and problem‑solving skills to site issues.
- Excellent written communication for timely reporting.
- Detail‑oriented with a focus on audit readiness.
Required skills
- Knowledge of ICH‑GCP guidelines.
- Experience with source data verification (SDR) and source data review (SDV).
- Familiarity with investigational product handling and documentation.
What we offer
- Opportunity to work on diverse global clinical trials.
- Collaborative environment with experienced project teams.
- Professional development in clinical monitoring and site management.
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Thermo Fisher Scientific
Argentine
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