Her work involves finalizing the budgets and other required documents during the project start-up phase, submitting and getting ethical approval from local IRB committee(s) and/or other relevant international EC boards, developing standard operating procedures to control the quality of study implementation, organizing logistics of study materials, including consumables, other studies’ materials and documents, and closely supervising the implementation of the studies.
Her work ensures efficient and high-quality research operation in line with international standards, including principles of Good Clinical Practice, tracking study progress and identifying problems, liaising with sponsors for monitoring/audits, and planning, implementing and coordinating all aspects of data collection and entering management and cleaning, and storage, following OUCRU’s data management policy and ICH GCP guideline.