プロフィール詳細

プロジェクトを作成

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Kinga K.に依頼

Poland

Clinical data analyst and medical writer with 4 years experience in clinical research and systematic review.

プロフィール概要

I am a clinical data analyst with 4 years experience with a university degree in biological sciences and several years of experience assessing the efficacy and safety of drugs and medical devices. I create multivariate analyses, use and manage data from source documentation, compile results, perform basic statistical analyses, and prepare reports for research teams. Each analysis is based on a comprehensive and systematic review of medical databases using keywords, publication selection, and subsequent data extraction. I have experience in verifying the consistency and completeness of data provided during trials, analyzing and reporting results, synthesizing data, and conducting meta-analyses. My skills include: - Management of research documentation in accordance with GCP principles and guidelines. - Preparation of HTA reports and assessment of compliance with regulatory provisions, i.e., AOTMiT, EMA, and FDA guidelines. - Knowledge of the reimbursement system in Poland and the medical procedure financing system. - Verification of the completeness and quality of data from conducted clinical trials. - Management of clinical trial databases, including certified knowledge of SQL. - Analytical thinking skills (basic knowledge of SAS). - Basic knowledge of clinical trial data management systems (EDC) and clinical trial management systems (CTMS). - Strong analytical and editorial skills in creating synthetic, expert content based on source documentation from clinical trials. - Knowledge of the principles of designing and conducting Phase I-IV clinical trials. - Knowledge of legal procedures and clinical documentation flow within a trial. - Knowledge of safety reports, pharmacovigilance procedures, and risk management plans. - Independently perform quantitative and qualitative analyses in accordance with SOPs and quality standards. - Knowledge of basic laboratory techniques, immunological and histological tests. My scientific achievements include 3 publications related to medical and reproductive health, published in international scientific journals with first authorship (Frontiers in Pharmacology, Reproductive Toxicology and Reproduction, Fertility and Development) and several co-authored publications.

専門分野

• ☆ Biostatistics
• ☆ Data Analysis
• ☆ SQL
• ☆ Clinical Trials
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Women's Health
• ☆ Ovarian Cancer
• ☆ Health Technology Assessment
• ☆ Medical Writing

サービス

• Writing

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

職務経験

Clinical Data Analyst

HEALTH QUEST SP. Z O.O.

9月 2023 - 現在

Clinical Data Analyst

CENTRUM HTA SP. Z O.O.

3月 2022 - 9月 2023

Research Worker

Jagiellonian University Cracow

10月 2018 - 6月 2022

学歴

Master's in Biological sciences

Jagiellonian University Cracow - Poland

10月 2019 - 7月 2021

Bachelor’s in Biological sciences

Jagiellonian University Cracow - Poland

10月 2016 - 7月 2019

認定資格

• MS Excel - intermediate level

  Imperium Szkoleniowe

  6月 2025 - 現在

• SQL language - basic level

  Imperium Szkoleniowe

  6月 2025 - 現在

• GCP - Good Clinical Practise

  Medical Research Agency

  1月 2025 - 現在

• Documentation in clinical trials

  Szkolenia biomedyczne

  1月 2025 - 現在

• Biostatistics in clinical trials

  Szkolenia biomedyczne

  1月 2024 - 現在

• Monitoring clinical trials - basic and advanced part

  Soft Communication

  10月 2022 - 現在

出版物

JOURNAL ARTICLE

Kinga Krawczyk, Katarzyna Śladowska, Przemysław Holko, Paweł Kawalec (2023). Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis . Frontiers in Pharmacology.

Justyna Gogola, Weronika Marynowicz, Kinga Krawczyk, Anna Ptak (2023). Visfatin increases the invasive potential of ovarian granulosa tumor spheroids by reprogramming glucose metabolism . Reproduction.

Justyna Gogola-Mruk, Kinga Krawczyk, Weronika Marynowicz, Magdalena Rokita, Samantha Nimpsz, Anna Ptak (2023). Bisphenols S and F drive ovarian granulosa cell tumor invasion via a metabolic switch . Toxicology Letters.

Justyna Gogola, Wacław Tworzydło, Kinga Krawczyk, Weronika Marynowicz, Anna Ptak (2023). Visfatin induces ovarian cancer resistance to anoikis by regulating mitochondrial activity . Endocrine.

Kinga Krawczyk, Weronika Marynowicz, Karolina Pich, Oliwia Jędruch, Gabriela Kania, Justyna Gogola-Mruk, Wacław Tworzydło, Zbigniew Polański, Anna Ptak (2022). Persistent organic pollutants affect steroidogenic and apoptotic activities in granulosa cells and reactive oxygen species concentrations in oocytes in the mouse . Reproduction, Fertility and Development.

Kinga Krawczyk, Weronika Marynowicz, Justyna Gogola-Mruk, Klaudia Jakubowska, Waclaw Tworzydlo, Małgorzata Opydo, Anna Ptak (2021). A mixture of persistent organic pollutants detected in human follicular fluid increases progesterone secretion and mitochondrial activity in human granulosa HGrC1 cells . Reproductive Toxicology.