Quality Specialist (Clinical Research QC Reviewer)

Position: Quality Specialist
Department: Clinical Operations
Employment Type: Full-Time Contractor
Schedule: Monday – Friday during Central Standard Time (CST) business hours
Location: Remote

Position Summary

The Quality Specialist is responsible for conducting quality control reviews of participant visits and source documentation within the CRIO eSource system. This role ensures that clinical documentation is complete, accurate, protocol-compliant, and aligned with Good Clinical Practice (GCP), ALCOA principles, and our clients quality standards.

This position requires an extremely detail-oriented individual who can identify inconsistencies, documentation gaps, and potential compliance concerns before they impact study quality. The adecuado candidate has previous experience as a Clinical Research Coordinator (CRC), Regulatory Specialist, or clinical research quality professional and can quickly adapt to established quality review processes.

Responsibilities

Responsibilities may include, but are not limited to:




- Review completed participant visits within the CRIO eSource platform using established quality control processes.
- Verify that all protocol-required procedures, assessments, and documentation have been completed accurately and appropriately documented.
- Review source documentation to ensure compliance with study protocols, sponsor expectations, site SOPs, and applicable regulations.
- Evaluate documentation against ALCOA and ALCOA+ principles to ensure data integrity standards are maintained.
- Identify missing documentation, inconsistencies, protocol deviations, transcription errors, and potential GCP concerns.
- Complete standardized QC Checklists to ensure consistency across studies and sites.
- Document findings thoroughly and objectively within designated tracking systems.
- Escalate significant quality findings according to established procedures.
- Collaborate with site personnel to communicate

📌 Quality Specialist (Buenos Aires)
🏢 UniTriTeam
📍 Buenos Aires