10 дней назад
Quality Assurance Specialist (Clinical Trials)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Specialist (Clinical Trials) (GCP/ICH/GLP): Auditing clinical study documentation, procedures, trial master files, source data, and site activities with an accent on regulatory compliance, documentation accuracy, and clinical research quality. Focus on conducting audits, analyzing non-conformities, supporting corrective and preventive actions, and coordinating with international study teams.
Location: 2421 W Peoria Ave, Phoenix, AZ 85029, USA
Company
SGS provides inspection, verification, testing, and certification services across multiple industries through an international network of offices and laboratories.
What you will do
- Review clinical study protocols, informed consents, case report forms, marketing materials, recruitment documentation, and sponsor final reports.
- Conduct audits of clinical trial master files, source data, study materials, internal departments, training files, and alternative study sites.
- Monitor clinical study procedures in clinics and verify compliance with protocols, monitoring plans, SOPs, and GCP/ICH requirements.
- Work with international coordinators, project managers, and other stakeholders to ensure accurate documentation and operational readiness.
- Support root-cause analysis, corrective and preventive actions, and review of clinical study protocol deviations.
- Train new departmental staff and help ensure equipment and operational needs are met.
Requirements
- Associate degree with 2–4 years of relevant experience, or bachelor’s degree with 1–3 years of relevant experience.
- Understanding of clinical studies and strong organizational, interpersonal, multitasking, and attention-to-detail skills.
- Knowledge of GCP, ICH, GLP guidelines, and federal regulations related to clinical trials.
- NIH training and the ability to work accurately with clinical research documentation.
Nice to have
- ISO 19011 internal auditing training.
Culture & Benefits
- Full-time employment with an equal opportunity employer.
- Work alongside international coordinators and project managers.
- Reasonable accommodations are available for qualified individuals with disabilities.
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