Clinical Quality Assurance (QA)

Quality Systems and Compliance

Support maintenance and continuous improvement of the Clinical Quality Management System (QMS)

Assist with SOP development, revision, and document lifecycle management

Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements

Audit and Inspection Readiness

Assist in planning and execution of internal and external audits (sites, vendors, CROs)

Support audit documentation, findings tracking, and CAPA activities

Contribute to inspection readiness efforts across clinical programs

CAPA and Quality Oversight

Track and support CAPA development, follow-up, and closure

Partner with Clinical Operations to ensure quality oversight across ongoing clinical trials

Support risk identification and quality issue resolution

Clinical Trial Support

Support development of clinical processes, tools, and study documentation

Ensure quality and consistency of clinical trial documentation

Training and Systems

Support development and delivery of GCP and QA-related training materials

Utilize and maintain systems such as eQMS, CTMS, and eTMF

Ensure accurate tracking and documentation within applicable systems