Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.

ROLE OBJECTIVES:

The Clinical Quality Assurance Associate supports the day-to-day management of GCP-related items within the Quality Management System (QMS) across all clinical activities, including decentralised clinical trials (DCTs) involving nursing services and in-home patient care. This role ensures that all clinical and nursing operations are conducted in accordance with ICH GCP, applicable regulatory requirements, and internal SOPs.

WHAT YOU’LL DO:

• Ensure GCP compliance and promote best practices across all regulated activities.
• Initiate and contribute to deviations, complaints, CAPAs, risk assessments, and validation protocols.
• Investigate deviations and complaints, and follow up on CAPAs to ensure timely resolution.
• Review clinical trial documents (e.g., protocols, ICFs, eCRFs) and essential records for accuracy.
• Review eTMF for completeness and accuracy, working with staff to resolve any deficiencies.
• Support clinical and nursing operations in managing QMS records, including change controls and risk management.
• Identify root causes of quality issues and recommend appropriate solutions.
• Assisted staff in training on QMS components and relevant procedures.
• Provide daily support on quality-related queries and maintain GxP documentation.
• Support vendor qualification and requalification, including audit preparation and participation.
• Contribute to internal audits and regulatory inspections as a subject matter expert.
• Generate quality metrics, analyse trends, and support process improvements and validation strategies.