プロフィール詳細

プロジェクトを作成

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Katerina S.に依頼

Greece

Experienced Medical Physicist with 20+ years in radiotherapy and clinical environments, expert in QA and clinical trials

プロフィール概要

I am a Medical Physicist with over 20 years of clinical and research experience in radiotherapy, clinical trials, and medical device applications. My career has focused on combining scientific expertise with regulatory and quality standards, ensuring safe, effective, and compliant patient treatments. In my clinical role at a private radiotherapy clinic in Greece, I have led treatment planning (Elekta Monaco v6.2), dosimetry, and quality assurance for a wide range of cancer therapies. I have also contributed to clinical trial implementation and monitoring, collaborating with multidisciplinary teams to maintain strict adherence to protocols, ethical guidelines, and regulatory frameworks. My skills include: Medical Writing & Regulatory Affairs: drafting and reviewing clinical trial protocols, informed consent forms, regulatory submissions, and QA documentation for medical devices. Clinical & Technical Expertise: radiotherapy planning, image-guided radiation therapy, dose verification, and system QA. Research & Publications: involvement in ongoing research projects in oncology, radiotherapy techniques, and medical device evaluation. Compliance & QA: experienced in ISO standards, Good Clinical Practice (GCP), and regulatory guidelines for clinical research and devices. I bring to every project a balance of technical precision, scientific communication skills, and regulatory insight. Whether supporting clinical trial documentation, regulatory submissions, or quality systems, I ensure clarity, compliance, and scientific rigor.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Medical Imaging/Radiology
• ☆ Interventional Radiology
• ☆ Nuclear Medicine
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Health Informatics
• ☆ Healthcare Administration & Management
• ☆ Hospital & Medical Facility Management
• ☆ Managed Healthcare
• ☆ Medical Practice Management
• ☆ Healthcare Quality Improvement
• ☆ Magnetic Resonance Imaging (MRI)
• ☆ Medical X-Ray
• ☆ Computed Tomography (CT)
• ☆ Mammography
• ☆ Positron Emission Tomography (PET)
• ☆ Ultrasound
• ☆ Image-Guided Biopsy
• ☆ DEXA Scan
• ☆ Fluoroscopy
• ☆ Diagnostic Radiology
• ☆ Medical Equipment & Supplies

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Translation

Research Technology Scouting, Fact Checking, Scientific and Technical Research

Consulting Healthcare Consulting, Scientific and Technical Consulting

Product Development Product Validation, Quality Assurance & Control (QA/QC)

職務経験

Medical Physicist

Athens Medical Center

10月 2002 - 現在

学歴

Radiation Physics-Medical Applications

University College London, University of London - United Kingdom

9月 1998 - 9月 1999

B.S. (Physics)

Queen Mary College, University of London

9月 1995 - 6月 1998

認定資格

• ICH Good Clinical Practice E6 (R2)

  The Global Health Network

  http://globalhealthtrainingcentre.org/elearning

  4月 2023 - 現在

• HOW TO CONDUCT GCP INSPECTIONS/AUDITS AT THE CLINICAL INVESTIGATOR SITE

  Global Health Training Centre

  http://globalhealthtrainingcentre.org/elearning

  4月 2023 - 現在