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senior CRA

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  • 44649 Herne
  • Europa
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  • 01.12.2012
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Kurzvorstellung

senior CRA, alle Phase I-IV, nahezu alle Indikatioen, alle Arten des Minitoring, Ethikeinreichungen ( auch nach neuen Gesetz )

Qualifikationen

  • Medizin

Projekt‐ & Berufserfahrung

CRA
Sponsoren, CROs, Europa
1/1995 – offen (30 Jahre, 1 Monat)
Gesundheitswesen
Tätigkeitszeitraum

1/1995 – offen

Tätigkeitsbeschreibung

Date Indication Phase No of sites No of patients
2012 CRO Psoriasis III 16 QV senior CRA
2012 Sponsor finished Intracerebral hemorrhage II 5 12 senior CRA
2010-2011 CRO finished Psoriasis II 4 40 senior CRA
2010-2010 CRO finished Lung Cancer II 1 55 senior CRA
2010-2010 CRO finished Diabetes mellitus I 1 12 senior CRA
2009-2010 CRO finished Prostate Cancer II 10 NA senior CRA
2009-2011 CRO finished Colon Cancer I QA
2009 CRO finished Incontinence( Medical Device) II 15 58 QA
2008-2010 CRO finished HIV (Vaccination) II 4 42 senior CRA
2008-2009 CRO finished SLE II 3 5 senior CRA
2008-2008 CRO finished Bioequivalence of a new formulation I 1 60 Lead CRA
2008-2008 CRO finished Bioequivalence of a new formulation I 1 55 Lead CRA
2008- 2008 CRO finished Neuropathic Pain ( Medical Device) II 3 6 senior CRA
2007-2008 Sponsor finished Prostate Cancer ( Medical Device) I 1 54 Lead CRA
2007-2008 CRO finished Chronic Pain I 1 45 Lead CRA
2007-2008 CRO finished Melanoma II 6 12 senior CRA
2006-2006 CRO cancelled Gout III 2 cancelled senior CRA
2006-2007 CRO finished Cholangio Cancer II 6 12 Lead CRA/QA
2006-2007 CRO finished Rheumatoid arthritis III 17 101 senior CRA
2006- 2009 Sponsor finished Stroke II 4 98 senior CRA
2006-2007 CRO finished Melanoma II QA
2006-2007 Sponsor finished Acute Stroke II 4 3 senior CRA
2006-2007 Sponsor finished Depression I 1 86 senior CRA
2005-2006 CRO finished Asthma (pediatric) III 12 25 senior CRA
2005-2007 CRO finished Diabetes ( Medical Device) III 11 87 senior CRA
2005-2006 CRO finished Staphylus aureus infection II 3 6 senior CRA
2005-2006 CRO cancelled Cholangio Cancer III 5 cancelled senior CRA
2005-2005 CRO finished Low Hemoglobin – Dialysis III 5 38 senior CRA
2005-2005 CRO finished Kidney Cancer III 3 15 senior CRA
2004-2005 CRO finished Hypertension III b 7 56 senior CRA
2004-2005 CRO finished Reflux Oesophagitis III 4 114 senior CRA
2004-2005 CRO finished Colon Cancer III 2 1 senior CRA
2004-2006 CRO finished Epilepsy III 17 26 senior CRA
2004-2004 CRO cancelled Prostate Cancer III 8 cancelled senior CRA
2003-2004 Sponsor finished Cardiac Shock III 5 12 senior CRA
2003-2006 CRO finished Diabetes III 15 86 senior CRA
2003-2005 CRO finished Rheumatoid Arthritis III 9 74 CRA
2000-2002 CRO finished Hypertension III b 29 197 CRA
1998-2000 Sponsor finished Diabetes III 12 114 CRA
1998-2000 CRO finished Depression III b 11 103 CRA
1996-1999 CRO finished Metabolic Disease/Diabetes III 16 85 CRA
1995-1997 CRO finished Asthma III 13 56 CRA
1995-1997 CRO finished Incontinence IV b 15 106 CRA

Zertifikate

GCP
2012

Ausbildung

Ökotrophologie
Ökotrophologie

Dortmund

Weitere Kenntnisse

Training: Monitoring training various CROs and Sponsor
SOP training various CROs and Sponsor
ICH-GCP” certified by Colloquium Pharmaceuticum
“12.AMG-Novelle” certified by KKS UKT Koordinierungszentrum Klinischer Studien Uni-Klinik Tübingen
„Qualität medizinischer Daten in Forschung und Versorgung” University of Essen
ICH-GCP”2008 certified by Clinrex GmbH
“ ICH-GCP-konforme Durchführung von klinischen Studien”
Cerificate No 10000058 Medical Consulting

Software:
Windows 8 - trained
MS-Office 2010 – trained
Experience:
Extensive experience in monitoring of phase I- IV studies, mainly conducted in Germany, Swiss, Austria, Netherlands and Belgium.
Experience in monitoring studies with medical devices.
Working with several electronic case report forms and electronic patient’s diaries.
* Inform * * RAVE * * OP-VERDI * * PRISM *
Working with several reporting systems
*Oracle* *CTMS* * Sponsor systems*
In addition experience in organization and conducting of training for physicians and study teams, as well as management of conferences, symposiums and administration and planning of finance budgeting.
Responsibilities include:
Site selection Visits * Pre-Study Visits * Initiation of Centers * Query Visits * All Aspects of Monitoring * Center Closure Visits
Audit and Inspection preparation * Independent Monitoring * Co-Monitoring * Quality Checks * Training of junior CRAs * Lead CRA function * Ethic Submission * GCP training of the study team * Project- management*

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Niederländisch (Fließend)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
1095
Alter
69
Berufserfahrung
30 Jahre (seit 1995)
Projektleitung
2 Jahre

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