Flora (Kwun Ping) Wong

Working on Diabetes studies from Phase II to Phase IV:

• Perform onsite and remote monitoring in UK: SIV, PSV, SDV, SDR, feasibility, close out,
• Managing ISF and safety reporting
• HRA, MHRA, Ehtics committee, NHS Trust collaboration and submissions
• Provide weekly study reports to study team
• Working in both Global studies and local studies
• Acting as main stakeholder for external and internal parties
• Editing and verifying Clinical Trials Documents
• Planning study logistics and budget calculation
• Implement CAPA and Audit preparation
• Support Contract Amendments and discussions
• Mentoring 3 Junior CRAs and 1 RA.

Working on Oncology and Intestinal Studies from Phase I to Phase III:

• Perform monitoring and close out activities around UK, including Ireland and Scotland
• Serve asthe primary point of contact for sponsors.
• SDV and SDR for eCRF and source documents with reviewing AEs/ SAEs and for safety reporting overall
• Ensure studies are ready for audit anytime and liaise with Site staffs to resolve queries
• Working with PI and site staffs to collaborate strategies for audit preparation
• Perform preparation of MHRA audit both onsite and back in the office
• Mentoring 1 Junior CRA for an audit.

Working on Bone surgery on Phase IV studies:

• Managing staffs for 2 Junior CRAs. Provide mentoring and training.
• Attend global team calls
• Perform monitoring evaluation visits with Junior CRAs
• Develop and facilitate trainings for internal colleagues
• Perform feasibility, start up and relative regulatory activities in Hong Kong and Singapore.

Working on Endocrine and Rare Diseases from Phase II and Phase III studies:

• Review and approve 10 monitoring visit reports and report with sponsor for site situations
• Perform monitoring evaluation visits with 2 Junior CRAs
• Develop and facilitate trainings for internal colleagues
• Provide trainings to internal and external staffs

Working on Circulatory, Respiratory, Eye and Nervous Diseases from Phase I to Phase IV:

• Managing Ethics Committee and Regulatory Authority submission/approval activities
• Translation and editing ICFs
• Writing SOP Training materials.

Working on Oncology, Diabetes, Respiratory, Circulatory, Infectious, Endocrine, Musculoskeletal diseases from Phase I to Phase IV:

• Conducting local feasibility, sites screening and selection
• Performing trials start up, monitoring and close out activities to local sites
• Facilitate Ethics Committee and Regulatory Authority submission/approval activities