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Quality Control Specialist
hace 2 semanas
Job description:
**Job Summary**
The Quality Control (QC) Specialist is responsible for implementing, managing, and overseeing quality control processes within clinical research operations. This role ensures that all aspects of clinical trials comply with protocols, Good Clinical Practice (GCP), regulatory guidelines, and organizational standards. The QC Specialist collaborates with site staff, Clinical Trial Managers (CTMs), and other departments to verify data accuracy, maintain documentation integrity, and ensure trial readiness for audits and inspections. This role requires a strong understanding of quality standards, regulatory compliance, and the ability to identify and mitigate risks proactively.
**Key Responsibilities**
- Develop and oversee quality control processes at clinical research sites.
- Review data for accuracy, consistency, and compliance with study protocols.
- Conduct regular monitoring visits and ensure adherence to regulatory standards.
- Support audit readiness and collaborate with QA teams during inspections.
- Train site staff on GCP, documentation practices, and internal procedures.
- Identify quality risks and implement corrective/preventive actions.
- Prepare and maintain audit-ready documentation and QC reports.
- Collaborate with CTMs, PIs, QA, sponsors, and CROs to ensure quality standards across all trial phases
**Requirements**:
- Proven experience in multi-site clinical trials and data verification.
- Strong knowledge of GCP, ICH guidelines, and regulatory bodies (FDA, EMA).
- Proficient with CTMS and EDC platforms.
- Excellent attention to detail, organizational skills, and communication abilities.
Tipo de puesto: Tiempo completo
Lugar de trabajo: Empleo presencial
Tipo de puesto: Tiempo completo
Lugar de trabajo: Empleo presencial
