Dr. Daniela Barke

D-16321 Bernau/Berlin
Mobile: +49 171 408 13 66
darke.daniela@t-online.de

Born in Wolmirstedt, 14.08.1972

Work experience

03/2003 – present: Freelance Monitor

  • 1 Phase IV studies in coronary heart disease
  • 2 Phase III studies in coronary heart disease
  • 1 Phase II studies in coronary heart disease
  • 3 Phase III in cardiovascular disease
  • 2 Phase III orthopedics
  • 1 Phase II stroke
  • 6 Phase III gastroenterology
  • 2 Phase II gastroenterology
  • 3 Phase II pulmonology
  • 4 Phase III pulmonology
  • 2 Phase III metabolic diseases
  • 2 Phase III transplantation
  • 1 Phase III study in dermatology, 13 sites
  • 1 Phase III study in urology, 4 sites
  • 1 Non-drug device, aneurism, 1 site
  • 1 Phase I study in gynaecology

05/20003 – 02/2003: Clinical Research Associate
Clinical Research Services, Kelkheim, Germany

  • 3 Phase IV studies in coronary heart disease
  • 4 Phase III studies in coronary heart disease
  • 1 Phase II studies in coronary heart disease

AREAS OF EXPERIENCE IN CLINICAL TRIALS

Cardiology, Dermatology, Gastroenterology, Pulmonology, Metabolism, Stroke, Orthopaedics, Transplantation, Urology, Gynaecology Web-based data capture: Cool, Phase Forward, eTrials, RAVE, Marvin

Education

  • 09/1996 – 04/2000 Doctoral studies at Friedrich-Löffler-Institute for Medical Microbiology, Greifswald, Germany Final qualification: Doctorate Degree
  • 09/1991 – 08/1996 Studies in Biology at Ernst Moritz University, Greifswald, Germany Final qualification: Univ. Degree in Biology

Professional training/certification

  • 02/2011 ICH-GCP, Parexel Akademie, Berlin, Germany
  • 02/2011 15. AMG, Parexel Akademie, Berlin, Germany
  • 06/2010 Form of contracts and tax law
  • 08/2009 Seminar Diabetes Mellitus
  • 11/2008 FDA Inspection
  • 11/2008 Clinical Trial for Children and Teens
  • 11/2007 Management English
  • 10/2007 Medizinproduktegesetz
  • 12/2006 Audit Findings and the Implementation into Clinical Trials
  • 12/2006 Accompanied Site Visits for Quality Assurance in Clinical Trials
  • 11/2006 English on the Job
  • 03/2006 American Collage of Cardiology, Atlanta, USA
  • 01/2006 “Changes according to 12.AMG-Novelle”
  • 12/2005 “12./14. AMG-Novelle and GCP-decree”
  • 11/2004 Workshop Monitoring and Refresher Training AMG/GCP
  • 02/2003 Seminar Gastroenterology
  • 07/2003 Workshop Interventional Cardiology
  • 12/2002 Communication workshop
  • 11/2002 Seminar Clinical Trials and other clinical investigations

Languages

German (native speaker)
English (fluent)

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