Vikki Semik

Bis 2016, Clinical Trial Manager, King's College London
Bad Rappenau, Germany

Fähigkeiten und Kenntnisse

Clinical Trial Management
Clinical Data Management
Clinical Monitoring
Regularien nach GCP
Data protection law
Clinical Research
Medical Devices
Immunology
Renal
Transplantation Medicine
Cancer Research
Time Management
Communication skills
Organisation
Laboratory Management
English Language
German language (A2 level)

Werdegang

Berufserfahrung von Vikki Semik

  • 1 year and 4 months, Feb 2015 - May 2016

    Clinical Trial Manager

    King's College London

    I managed PAVE (Paclitaxel-assisted balloon Angioplasty of Venous stenosis in haEmodialysis access), a UK multi-centre RCT, through its set-up & early recruitment phases [ISRCTN 14284759]: - obtaining Research Ethics Committee approval - obtaining NHS Permission - development of trial management documentation - site selection and set-up (national) - substantial / non-substantial amendments - safety reporting - progress reporting

  • 8 months, Jul 2014 - Feb 2015

    Clinical Trial Administrator

    King's College London

    I was responsible for all administrative aspects of SMILE UK (Self-Management education for adults with poorly controlled epILEpsy), a UK multi-centre RCT [ISRCTN 57937389]. - assisted with patient recruitment & retention - oversight of self-management courses - data management - source data verification - maintenance of TMF and SOPs - organisation of meetings (including minute-taking) - preparation of newsletters - managing/tracking trial documentation

  • 3 years and 11 months, Sep 2010 - Jul 2014

    Clinical Research Assistant

    King's College London

    - Conducted work on an independent research project - Additionally, assisted the manager of OuTSMART (Optimised TacrolimuS & MMF for HLA Antibodies after Renal Transplantation), a UK multi-centre phase IV RCT [ISRCTN 46157828] - Acted as Local Health & Safety Officer for the shared laboratory space - Managed all laboratory documentation for research work which was covered by Human Tissue Act regulations & prepared the group for audits

  • 1 year and 9 months, Oct 2008 - Jun 2010

    Research Specialist

    The University of Arizona College of Medicine - Phoenix

    - Conducted work on an independent research project - Provided support to other laboratory members - Managed general laboratory processes & administration

Ausbildung von Vikki Semik

  • 10 months, Sep 2015 - Jun 2016

    Clinical Trials (by distance learning)

    London School of Hygiene and Tropical Medicine

    Modules: - Fundamentals of Clinical Trials - Clinical Trials in Practice

  • 1 year and 7 months, Dec 2006 - Jun 2008

    Molecular Medicine

    Trinity College Dublin

    Research title: The role of 12-lipoxygenase in non-small cell lung cancer

  • 4 years and 10 months, Sep 2001 - Jun 2006

    Immunology with industrial placement

    University of Aberdeen

    Final year project title: A change of inflammatory phenotype for epithelial cells: a potential therapy for asthma?

Sprachen

  • English

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    A1-A2 (Grundkenntnisse)

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