プロフィール詳細

プロジェクトを作成

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Lisa N.に依頼

Australia

Ethical AI & Health Compliance Consultant | Evidence-Based Research & Documentation Specialist | Remote | ISO/TGA/GCP

プロフィール概要

I am a medical doctor (MBChB) and MBA-qualified compliance specialist with 20+ years’ experience in clinical research, data ethics, and responsible AI. I help organisations, universities, and research startups ensure their projects align with global ethical, legal, and quality standards — translating complex evidence into clear, actionable frameworks. My focus is on low-pressure, high-integrity support: well-documented, structured deliverables completed flexibly and asynchronously. Clients often engage me to review or author small components that require scientific accuracy, ethical awareness, and strong attention to regulatory detail. Areas of Expertise: Health & Medical Research Compliance: ISO 13485, TGA, MDR, GCP AI Ethics & Governance: Human-in-the-loop systems, transparency, bias mitigation Policy & Documentation: Clinical research protocols, SOPs, ethics submissions Data Management & Ontology Mapping: Formal logic frameworks for structured compliance Quality Audit & Risk Assessment: Real-world evidence alignment with safety standards Scientific & Technical Writing: Reports, literature reviews, educational content Ethics & Social Justice Integration: Responsible innovation and equitable technology design Services Offered: ✅ Regulatory or Ethics Document Review Review research proposals, SOPs, or compliance reports for ethical or legal alignment Annotate using ISO/TGA/GCP reference mapping ✅ Ethical AI Policy or Framework Writing Draft short-form frameworks or policy briefs for emerging AI systems Integrate principles of transparency, accountability, and bias prevention ✅ Clinical Research Support Literature summaries, risk register development, data integrity audits Preparation of training or quality manuals ✅ Ontology or Structured Data Consulting Advise on how to build or validate a lightweight ontology for healthcare data or compliance Review terminology for logical or ethical consistency ✅ Scientific & Educational Writing Summaries, explainer articles, or ethics-based learning modules (healthcare, AI, social impact) Work Style & Availability: Remote only | Flexible hours (asynchronous communication preferred) Turnaround: 3–7 days for small projects; longer timelines for in-depth reviews Communication: Written updates and milestone-based progress tracking Timezone: Brisbane, Australia (AEST, UTC+10) Education; MBA (London Business School, UK) – Distinction, Ethics & Strategy focus MBChB (University of Stellenbosch, South Africa) AMC Bridging Certificate, Australia RACGP CPD Educator Certification Recent Projects (Examples): Authored “AI Ethics Risk Checklist” for medtech startup compliance readiness (ISO 13485). Reviewed and annotated university ethics applications for clinical data reuse. Designed a light ontology schema linking patient safety metrics to regulatory KPIs. Created compliance-tracking dashboards using Microsoft Excel and risk-weighted metrics. Edited white paper on integrating AI ethics into hospital research frameworks. Typical Project Budget: Small projects (document review or writing): AUD 300–900 Medium projects (policy, framework, ontology mapping): AUD 1,000–2,500 Hourly consulting (ad-hoc expert input): AUD 90–120/hr Keywords: AI ethics, compliance, healthcare research, ISO 13485, MDR xxxxxxxx, data governance, ontology, medical writing, risk management, ethical innovation, GCP, TGA, regulatory documentation, policy drafting, human-in-the-loop AI, knowledge translation

専門分野

• ☆ Biostatistics
• ☆ Data Analysis
• ☆ Computer Simulation/Computational Modeling
• ☆ Algorithm Design
• ☆ Predictive Modeling & Analytics
• ☆ Data Processing
• ☆ Data Exploration
• ☆ Cluster Analysis
• ☆ Data Visualization
• ☆ Big Data Analytics
• ☆ Data Collection
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Machine Learning
• ☆ Text Mining & Analytics
• ☆ Data Mining
• ☆ Data Cleaning
• ☆ Natural Language Processing
• ☆ Data Architecture
• ☆ Pattern Recognition
• ☆ Artificial Intelligence
• ☆ Fuzzy Logic
• ☆ Statistics
• ☆ Statistical Theory
• ☆ Applied Statistics
• ☆ Comparative Analysis
• ☆ Social Statistics
• ☆ Meta-Analysis
• ☆ Regression Analysis
• ☆ Multivariate Analysis
• ☆ Nonlinear Regression
• ☆ Bayesian Statistics
• ☆ Correlation Analysis
• ☆ Quantum Statistics
• ☆ Statistical Computing
• ☆ Mathematical Statistics
• ☆ Survey Design
• ☆ Study Design
• ☆ Statistical Review
• ☆ Medical Statistics
• ☆ Health Data Analysis
• ☆ Trend Analysis
• ☆ Knowledge Management
• ☆ Taxonomy/Classification
• ☆ Data Archaeology
• ☆ Decision Science
• ☆ Information Retrieval
• ☆ Library & Information Science
• ☆ Abstracting & Indexing
• ☆ Digital Libraries
• ☆ Library Reference Services
• ☆ Risk Assessment & Actuarial Science
• ☆ Information & Knowledge Management
• ☆ Data Storage
• ☆ Medical Libraries
• ☆ SPSS
• ☆ Matlab
• ☆ SQL
• ☆ Excel
• ☆ LaTex
• ☆ R
• ☆ Markup Languages
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Primary Care/Family Medicine
• ☆ Human Biology
• ☆ Preventive Medicine
• ☆ Precision Medicine
• ☆ Pain Management
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Managed Healthcare
• ☆ Healthcare Quality Improvement
• ☆ Medical Terminology
• ☆ Medical Sciences
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ User Research
• ☆ Quantitative User Research
• ☆ Qualitative User Research
• ☆ Meta-Research
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Instructional Webinars
• ☆ Continuing Medical Education (CME) Training
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Continuing Medical Education (CME) Materials
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Cochrane Reviews
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ SOP & Protocol Writing
• ☆ Science Communication
• ☆ Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, General Proofreading & Editing

Research Meta-Research, Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Digital Strategy Consulting, Healthcare Consulting, Regulatory Consulting

Data & AI Predictive Modeling, Statistical Analysis, Algorithm Design-Non ML, Algorithm Design-ML, Data Visualization, Text Mining & Analytics, Data Mining, Data Cleaning, Data Processing, Data Insights

職務経験

Ethical AI & Health Compliance Consultant

Freelancer/Independent

1月 2025 - 現在

学歴

MBA

London School of Business & Finance - United Kingdom

10月 1996 - 10月 1998

Medical Degree (MD)

Stellenbosch University

1月 1987 - 12月 1992

認定資格

• MBA

  London Business School

  https://www.london.edu/masters-degrees/mba

  10月 1998 - 現在

• MBChB

  University of Stellenbosch

  https://www.su.ac.za/en

  12月 1992 - 現在

出版物

JOURNAL ARTICLE

Ian Ferguson, Anthony Bell, Greg Treston, Lisa New, Mingshuang Ding, Anna Holdgate (2016). Propofol or Ketofol for Procedural Sedation and Analgesia in Emergency Medicine—The POKER Study: A Randomized Double-Blind Clinical Trial . Annals of Emergency Medicine.