Quality Control (QC) Specialists-Clinical Research

Angels Clinical Research Institute

Job Description

Position Summary:
The QC Specialist is responsible for ensuring the accuracy, completeness, and compliance of clinical trial documentation and data across all research sites. This role performs ongoing quality checks of source documents, regulatory files, and study data to maintain audit readiness and adherence to protocol, GCP, and sponsor requirements.

Key Responsibilities:

Perform routine QC reviews of:
- Source documents
- Informed consent forms (ICFs)
- Regulatory binders / eISF
- EDC entries vs source (SDV support)
Identify and flag:
- Missing documentation
- Data discrepancies
- Protocol deviations
- GCP compliance gaps
Ensure all documentation meets:
- ALCOA+ principles
- Sponsor and protocol requirements
- FDA / ICH-GCP standards
Track and follow up on QC findings until resolution
Support audit and inspection readiness across all sites
Work closely with:
- Study coordinators
- Investigators
- Regulatory team
Assist with:
- CAPA development and implementation
- SOP adherence and training reinforcement

Key Skills:

Strong attention to detail
Analytical and problem-solving skills
Ability to identify trends and recurring issues
Organized and able to manage multiple studies/sites
Strong communication and follow-up

Apply

Vacancy posted 7 days ago

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