Sabine Harrant
Clinical Monitor / CRA | Project Manager

Sabine Harrant

Curriculum vitae

Education
1990
Vocational Business School Vöcklabruck
1994
Medical Technical Analyst, Linz General Hospital
2000
Administrator of Clinical Studies
2001
Competence Certificate Clinical Monitor / CRA, Vienna
2004
Update competence certificate Clinical Monitor / CRA
Work Experience
1990 to 1992
S-Bausparkasse, Customer Service Representative
1995 to 1996
WELS HOSPITAL, Medical Technical Analyst, Pathology 2 (Microbiology)
1997 to 2001
Mayrhofer Pharmazeutica, Diagnostics Counselor
2001 to 2006
Quintiles, Clinical Research Associate
2007
Mag. Andreas Raffeiner GmbH, Clinical Research Associate

Special skills

Foreign Languages
  • German (mother tongue)
  • English (confident in business and discussions)
  • French (basic knowledge)
Computer Skills
  • MS-Office
Other
  • Local Trainer for Internet-based data capture systems (Inform)
  • Data capture programs: Inform, IMPACT, COOL, RAVE, StudyMate

Experience

Experience
Phases I - IV
CARDIOLOGY (20 patients)
  • Anti-thrombotic therapy following STEMI / NSTEMI
CENTRAL NERVOUS SYSTEM (40 patients)
  • Depression
  • Bipolar Disorder
DERMATOLOGY (40 patients)
  • Contact dermatitis
GASTROENTEROLOGY (> 200 patients)
  • Gastroesophageal reflux disease (GERD)
METABOLIC DISEASES (20 patients)
  • Diabetes mellitus type 2
ONKOLOGY (> 20 patients)
  • Breast cancer
  • Colorectal cancer
  • STNM
  • Ovarian carcinoma
  • Cervical carcinoma
  • Endometrial carcinoma
PULMONOLOGY (180 patients)
  • Bronchial asthma
RHEUMATOLOGY (25 patients)
  • Rheumatoid arthritis
EMERGENCY STUDY
  • Trauma patients
NON-INTERVENTIONAL STUDIES IN THE FOLLOWING CORE THERAPEUTIC AREAS:
  • Rheumatology (200 patients)
  • Psychiatry (50 patients)
  • Nephrology (50 patients)
  • CNS (40 patients)
  • Dermatology

Training details

Training details
09/17/2001 to 09/29/2001
Seminar diploma: CRA Training
06/10/2003 to 06/11/2003
Seminar diploma: Quality standards in clinical trials
06/11/2003
Seminar diploma: GMP
02/20/2004
IMPACT Training
04/20/2004
Seminar diploma: Complaints management
04/20/2004
Seminar diploma: EU directive basis
05/05/2004
Seminar diploma: EU directive follow-up
05/10/2004 to 05/11/2004
Seminar diploma: CRA training follow-up
03/15/2005
Seminar diploma: Laboratory data in clinical studies
06/13/2005
COOL training
10/19/2005
INFORM V4.0 training + trainer training
02/27/2007 to 02/28/2007
Seminar diploma: Rhetoric – Presentation techniques
03/09/2007
Seminar diploma: Time Management
05/30/2007
Seminar diploma: No fear of GCP audits and inspections, Vienna
06/25/2007
Seminar diploma: Advanced Study Management
11/08/2007 to 11/10/2007
Management I - My role as a leader
01/23/2008
EDC (electronic data capture) RAVE training Version 5.5 EDC
09/19/2008
Seminar diploma: Neurology and Psychiatry Workshop, Sophie Förster-Streffleur, MD
02/20/2009
Seminar diploma: Immunology intensive, Sophie Förster Streffleur, MD
07/16/2009
Intramural continuing education seminars:
  • Patient Information in Minors/Children
  • News from the seminar "Study Management Advanced"
  • News from the seminar "AMG Amendment 2009"
  • Conduct of a Close out visit
  • Workshop "How to take positive influence on the recruiting process?"
12/01/2009
Seminar diploma: AMG Amendment 2009
02/24/2010 to 02/26/2010
Intramural continuing education seminars:
  • News from the Seminar "Medicine Products Act"
  • News from the Seminar "Pharmacovigilance Compact"
  • Management Manual Mag. Andras Raffeiner GmbH
03/04/2010
Seminar GPMed: "Contracts for Clinical Trials at Austrian Universities - Demands and Experiences"
04/14/2010
Seminar diploma: "Clinical Studies in Children & People who are Unable to Offer Consent"
06/15/2010
Seminar GPMed: "Results of Inspections in Austria and Comparison Within the EU"
06/16/2010 to 06/18/2010
Team Seminar: Communication, Mag. Erwin Datscher, ProConsult, St. Stefan am Walde
09/24/2010
Seminar diploma: Oncology, Beate Mayrbäurl, MD; Linz
10/05/2010
Seminar: Clinical Trials update, Vienna
12/02/2010
Seminar GPMed: "When does a substance apply as an investigational medicinal product (IMP) in a clinical study and when not?"
03/31/2011
Seminar diploma: Ethics committee in clinical research, Univ.-Prof. Dr. Ernst Singer, Vienna
10/10/2011 to 10/12/2011
Seminar: The GCP Auditor, Vienna
04/23/2012
Seminar: Psychology of auditing, Vienna
05/15/2012
Sponsor: CRA Protocol online training
05/18/2012
Sponsor: Contractor Self Study Training log (Eu-SOP-0012 V4.0, 0013 V5.0, 0014 V2.0, 0094 V2.0, 0121 V1.0, Eu-RD-1311 V5.0, CTD-SSM-023 V6.0, SOP R-0149 V6.0)
07/20/2012
Sponsor: Contractor Self Study Training log (EuRD-0013 Version 6.0)
07/24/2012
Sponsor: Contractor Self Study Training log (EuRD-1310 Version 7.0)
09/05/2012
Sponsor: Contractor Self Study Training log (EuRD-0012 Version 5.0)
09/21/2012
Sponsor: Contractor Self Study Training log (EuRD-0082 Version 2.0)
11/23/2012
Sponsor: Contractor Self Study Training log (EuRD-0082 Version 3.0)
02/14/2013
Sponsor: Contractor Self Study Training log (EuRD-0071 Version 3.0)
03/12/2013
Driver Safety Training 1
04/22/2013 to 04/23/2013
Presentation seminar
11/04/2013
Professional teams invest in themselves
06/21/2017
"How to arrange contact", Pro-Consult by Mag. Erwin Datscher
10/17/2017
EU Telecommunications Data Protection Ordinance (DSGVO), Mag. Christina Koblbauer BSc.
10/17/2018
Update Clinical Trial Regulation, Mag. Andreas Raffeiner