Stefanie Steininger BSc.
Clinical Monitor / CRA | Project Manager

Stefanie Steininger BSc.

Curriculum vitae

Education
2010
Competence Certificate Clinical Monitor / CRA, Vienna
2011
Bachelor Degree in "Health and Nursing Science", Medical University Graz
Work Experience
2010 to 2013
QPS Austria GmbH, Clinical Research Associate, Clinical Enrollment Manager
2013 to 2014
Covance Clinical and Periapproval Services GmbH / CoSource, Clinical Research Associate for Sanofi Germany GmbH
2014
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
  • MedDRA, SPSS
Other
  • Monitor reporting systems: IMPACT, MySite, Clinphone, Cenduit
  • Data capture programs: Inform 4.6, Aris Global, Oracle, OC/RDC

Experience

Experience
Phases I - IV
CARDIOLOGY
  • Acute coronary syndrome
  • Myocardial infarction
  • Heart failure with preserved ejection fraction (HFpEF)
CENTRAL NERVOUS SYSTEM
  • Alzheimer's Disease
  • Mild Cognitive Impairment
DERMATOLOGY
  • Psoriasis
ENDOCRINOLOGY
  • Diabetis mellitus
IMMUNOLOGY
  • Hexa-vaccine DTaP-IPV-HB-Hib
ORTHOPAEDICS
  • Cartilage lesions of the knee (ACI)
RHEUMATOLOGY
  • Scleroderma
  • Ankylosing Spondylitis
  • Axial Spondyloarthritis

Training details

Training details
03/01/2010
Seminar diploma: The legal essentials and requirements for Clinical Trials, DDr. Alexander Hönel & MMMag Bernd Unterkofler, HealthCare Consulting GmbH
03/02/2010 to 03/03/2010
Seminar diploma: The Clinical Monitor/CRA- funktions, responsiblity, planing, trial, DDr. Alexander Hönel, Mag. Andreas Raffeiner, HealthCare Consulting GmbH
03/22/2010
Seminar diploma: The Clinical Monitor/CRA- funktions, responsiblity, planing, trial, DDr. Alexander Hönel, Mag. Andreas Raffeiner, HealthCare Consulting GmbH
03/23/2010
Seminar diploma: Internal and external documentation obligation in Clinical Trials, Mag. Andreas Raffeiner, HealthCare Consulting GmbH
06/01/2010
Qualification-Certificat "Qualified Clinical Monitor/CRA", Mag. Dominik Flener und DDr. Alexander Hönel, HealthCare Consulting GmbH
07/01/2010
Project Management Training, Angela Hansen, Milestone Program Management
06/30/2010 to 07/02/2010
International Clinic Meeting: GCP Audits and Inspections, The LAboratory Visit, Pharmacovilgilance, SAE Reporting
04/01/2011
GCP Refresher Course - A Practical Workshop, Ruth Poltsch
04/19/2011 to 04/20/2011
Rater Training - A Practical Workshop (ADAS-cog, NPI, ADCS-ADL, FCSRT, MMSE, QoL, VerPA, DS, CFT, CDR), Mag. Claudia Bauernhuber, Mag. Nadja Windisch
06/30/2011
Seminar diploma: SAE Reporting in Clinical Trials, Gerlinde Pichler-Steiner, Mag. Andreas Raffeiner, HealthCare Consulting GmbH
10/17/2011
Training in Biomarkers of Alzheimer's Disease, Manfred Windisch PhD.
11/08/2011 to 11/10/2011
Seminar diploma: Project Management Clinical Trials, Mag. Dominik Flener, Mag. Andreas Raffeiner, HealthCare Consulting GmbH
11/12/2011 to 11/17/2011
XXth Word Congress for Neurology WCN 2011, Vladimir Hachinski, Mostafa El Alaoui Faris, Werner Hacke, Marrakesh
12/15/2011
Refresher Training Biomarkers of Alzheimer's Disease (NINCDS-ADRDA, PiB-PET, CSF biomarkers, ADNI CSF-Imaging), Manfred Windisch PhD
02/28/2012 to 02/29/2012
Clinical Enrollment Director & Clinical Enrollment Manager Workshop, Linda Goldman
06/27/2012
GCP web based training
07/07/2012 to 07/18/2012
Communication- and Conflictmanagement Seminar for CRAs, Mag. Claudia Bauernhuber, Mag. Nadja Windisch, Wendepunkt
10/04/2012
"Stroke" Training, Dr.med. Thomas Gattringer, Medizinische Universität Graz
10/12/2012 to 10/13/2012
25th annual converence of the Austrian Alzheimer-Association
11/07/2012 to 11/08/2012
Certificat "Monitoring advanced", Susanne Zeller, Dr. Gerlinde Lang, Forum - Institut für Management
12/07/2012 to 12/10/2012
8th International Winter Converence of Alzheimer's Disease IWCAD 2012, Manfred Windisch PhD., Prof. Abraham Fisher, Prof. Ezio Giacobini
12/13/2012
"Medical Devices in Clinical Trials", Marcus Hahn PhD.
12/28/2012
Vaccine Trials: Methods and Best Practices, John Hopkins University via coursera.org
05/13/2013
Internal DGPharMed Kongress Update, Deutschland
06/11/2013
Safety Training SAE / DIL / IB / DSUR Handhabung, Germany
07/23/2013
Federal Law of Switzeland about drugs and Medical Devices (Therapy-Law) of 05.12.2000 & regulation about Clinical Trials with drugs of 01.01.2008, stand 01.07.2009, Germany
12/08/2013
IMPACT Polaris MySites Module, Germany
12/09/2013
Inform 4.6 PhaseForward eCRF Training
12/13/2013
Advanced Training x-ray regulation & radiation protection regulation, Germany
09/26/2014
OC RDC Onsite eCRF
01/14/2015
Seminar: Data Protection Rights & Practice in the Pharmaceutical Industry, Dr. Rainer Knyrim, Dr. Gerhard Kunnert, Pharmig Academy Wien
01/19/2015
Good Clinical Practice Certificate, Novartis GmbH
04/22/2015
Clinical Studies in Medical Devices, Dr. DI (FH) Michael, RnB Medical Software Consulting GmbH, Linz
04/21/2015 to 04/22/2015
Spring Meeting
  • GCP Findings 2013, FDA-Findings
  • Compassionate Use
  • Medical device law with DI (FH) Dr. Michael Ring
07/20/2015 to 07/21/2015
Summer Meeting
  • Seminar diploma: Time Management, Mag. Erwin Datscher, Pro Consult
07/21/2015
Training: How to use a fire extinguisher, FF Walding
12/16/2015 to 12/17/2015
Conflict Resolution in the Clinical Trial, HealthCare Consulting GmbH
04/20/2016
Project Management-Tools for Clinical Trials, HealthCare Consulting GmbH
05/11/2016
Symposium Clinical Research in Austria - Current Situation and future Perspective, GPMed
11/21/2016 to 11/23/2016
GCP Compliance Trainin for CRAs and CRA Manager, Marc Bettscheider, Novartis Wien
12/12/2016
Patient Education in Clinical Trials, GxP Konkret
12/16/2016
Setting Limits - Strengthening Resilience, Mag. Manuela Dorninger
03/15/2017 to 03/16/2017
Operational Excellence in Clinical Trials (OECT) Summit: Study Feasibility and Patient Recruitment Retention
04/24/2017
IATA Training, Nicole Dechel, Dekra, Novartis Wien
06/22/2017
Utility and importance of clinical studies: The new clinical trials regulation and their practical impacts on clinical studies in Austria
07/17/2017
"How to arrange contact", Pro-Consult by Mag. Erwin Datscher
10/17/2017
EU Telecommunications Data Protection Ordinance (DSGVO), Mag. Christina Koblbauer BSc.
10/17/2017
Update Clinical Trial Regulation, Mag. Andreas Raffeiner