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Teresa oversees the Systems Operations and Quality Assurance functions of the organization to ensure planning, coordination, control, and continuous improvement of internal systems, processes and methods are set up to control the quality of studies conducted at OnQ Research. Teresa has worked extensively in the industry, mostly with CROs. Her experience includes Clinical Research Management, Project Management, Clinical Operations Management, Auditing and Consulting. She currently leads a team that focuses on continuous improvement on projects using approved tools, design control, validations, and ensuring adherence to agency regulations, GxP, Industry Guidelines, local regulations, along with OnQ Research policies and procedures for the conduct of clinical trials. This involves working closely with Clinical Operations, Data Management and Information Technology, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.
Develop, maintain, and implement ICH GCP and local regulatory compliant systems and processes which control the quality of work and clinical trials conducted at OnQ Research.
Lead or consult with identifying and managing non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, QMS, Quality System Regulations and / or ISO standards where applicable.