Clinical QA Specialist — GCP/ICH Compliance

SGS North America Inc.

Richardson (TX)

On-site

USD 65,000 - 90,000

Full time

14 days+

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Job summary

SGS North America Inc. is seeking a QA Specialist to ensure compliance with protocols, federal regulations, SOPs, and company procedures.

The role involves reviewing protocols, informed consents, CRFs, and study materials, auditing master files, source data, and training files, and coordinating with international teams to ensure accurate documentation for clients. The candidate will monitor internal studies, assist with CAPAs, and train new staff while upholding GCP/ICH guidelines and federal

Qualifications

Bachelor's degree and 1–3 years of relevant experience in clinical trials or regulated environments.
Knowledge of GCP/ICH/GLP guidelines and Federal regulations related to clinical trials.
Ability to understand clinical studies and maintain protocol and regulatory documentation.

Responsibilities

Ensure compliance with protocols, regulations, SOPs, and company procedures.
Review protocols, informed consents, and case report forms prior to study initiation and revisions.
Coordinate with international coordinators and project managers to ensure accurate documentation for clients.
Review marketing and recruiting documentation for compliance.
Audit study material receipt, return/destruction, and in-clinic procedures.
Audit clinical trial master files, source data, and SOPs for GCP/ICH compliance.
Review Final Reports and assist with auditing training files.
Monitor internal studies and alternate sites; document non-conformities and corrective actions.
Provide training to new departmental staff; collaborate with all involved parties.