Quality Assurance Specialist

Responsibilities

• Review protocols, informed consents, and case report forms (CRFs)
• Work with international coordinators and project managers to ensure accurate documentation
• Audit study material receipt, return, and destruction
• Conduct audits of clinical trial master files, source data, and procedures for GCP/ICH compliance
• Perform in-clinic audits of study procedures
• Assist with documentation of non-conformities, corrective actions, and preventive actions
• Monitor internal studies and alternative sites
• Oversee lab safety and take prompt corrective action for unsafe conditions
• Train new departmental staff

Requirements

• Bachelor's degree
• 1-3 years of relevant experience
• Demonstrated ability to understand clinical studies
• Knowledge of GCP, ICH, GLP guidelines, and Federal Regulations related to Clinical Trials
• NIH training
• Strong organizational and multi-tasking skills

About the Company

SGS is the world's leading testing, inspection and certification company, recognized as the global benchmark for sustainability, quality and integrity.