2025 Austin Section May General Meeting

Bio: 

Dr. Fox holds her doctorate in Healthcare Administration. She started in the research field as a research coordinator in cardiology. Additional areas of expertise focus on early phase human pharmaceutical clinical research and device development in the specialties of pediatrics, oncology, neurology, infectious disease, dermatology and diabetes. Areas of expertise include Good Clinical Practice experience in clinical trial programs, auditing, operations and regulatory compliance. 

 

Prior to auditing she has served in roles at the site level as a certified clinical research study coordinator and eventually progressed to management of several large academic clinical research programs. Additional auditing experience involved many years doing internal audits and QA work at sites that had NIH or grant funds that do not require audits like Pharma. She coached and assisted with preparation for pharma projects writing SOPs, process work, education courses and other work to resolve CAPAs. Additional qualifications include serving in clinical research consultant roles, a board member of local and national clinical research organizations and as an adjunct professor of healthcare administration at a local university.

• Standard Operating Procedures (SOPs) and Company (Site) Policies
• Learning Management- Staff oversight procedures, training processes including review of Curriculum Vitae (CVs), Job Descriptions and training records for employees and contract staff
• Vendor management including service providers and site processes, and their associated deviations/quality issues/CAPAs
• Quality issues/deviations/CAPA review
• Health Information Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR) and Data Privacy compliance

• Contracts and agreements
• Institutional Review Board (IRB)/Ethics Committee
• Informed Consent
• Investigational Product (IP)/Pharmacy storage, accountability, randomization, & blinding
• Sample/specimen management
• Monitoring
• Principal Investigator (PI) oversight and escalation
• Protocol adherence and non-compliance
• Risk management
• Safety reporting
• Communication Escalation
• Study workflow assessment

• IP management
• Shipment, temperature management, storage
• Equipment maintenance and calibration

• Good Documentation Practices
• Data integrity and accuracy
• Trial Master File management
• Data Handling, Processing and Storage
• Data acquisition review
• Data access management throughout study lifecycle, including data storage
• Data transfers process, including test transfer

• Facility and Equipment
• Computerized Systems (relative to provided services, including but not limited to, validation, change control, security, physical/logical access, back-up, and recovery)

• Delegation
• Informed consent process
• Source documented, eCRF data completion
• AEs and SAEs reporting and management
• Compliance management (subject eligibility, protocol deviations)
• Interaction with Monitors