The Quality Assurance Specialist is responsible for ensuring compliance with protocols, regulations, industry guidelines, and company procedures in clinical trial processes.
They review study protocols, informed consents, case report forms, and marketing materials, and conduct audits of study documentation, source data, and study procedures to verify GCP, ICH, and SOP adherence.
The role involves monitoring study sites, assisting with non-conformity documentation, and training new staff.
Additionally, they oversee equipment and safety protocols in the lab, promote health and safety reporting, and support internal study monitoring.
Qualifications include a bachelor’s degree, 1-3 years of relevant experience, and knowledge of clinical study regulations and guidelines.
They must possess strong organizational skills, attention to detail, and the ability to multitask.
The position emphasizes equal opportunity employment and may include duties outside the core scope as assigned.