Gudrun Reider

Am Käsberg 3a
D-64646 Heppenheim
Phone: +49 6253 989 120
Fax: +49 6253 989 121

gudrun.reider@cra-freelance.net

Experience

Familiar with clinical research processes since 1993, self employed since 2002

Currently working as freelance CRA in clinical research

  • Monitoring and management of international and national studies phases 1-4 as Clinical Research Associate
  • Special experience in the indication diabetes (14 years ongoing experience in all indications), gastroenterology, AIDS, leukemia, severe head injury, subarachnoidal hemorrhage, alcoholism, heart insufficiency. For details see experience list.
  • Guaranteed use of electronic CRFs / CTMS: COOL, ATLAS, LOTUS  Notes, IMPACT, InForm

Previous career as employee in the pharmaceutical industry

  • Project management of national study teams as local trial manager for all phases; responsibility for all issues and milestones including budget, international communication, organization and realization of meetings, submission to Austrian Ethics Committee and Health Authorities
  • Preparation of / participation in audits and inspections (pharmaceutical companies, CRO, Austrian Health Authority, FDA)
  • Monitoring of national and international studies phases 1-4 (from feasibility to site closures)

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

Employments

  • 2002-ongoing Freelance Senior CRA and local trial manager
    For diverse clients: Monitoring of all study phases incl. phase 1 trial management, audits, performance of co-monitoring visits
  • 1996-2002 CRA/Senior CRA and local trial manager Novo Nordisk Pharma GmbH Mainz
  • 1993-1996 CRA
    Upjohn GmbH Heppenheim/Erlangen

Education

  • Since 1993 Continuous qualifications in processes of clinical research at pharmaceutical companies, contract research organizations and other. For details see training record.
  • 1985-1993 University degree Diploma Biology
    Technical High School Darmstadt
    Studies of Biology with main subject microbiology
    Practical outdoor works with Bacillus thuringiensis israelensis during biological studies (KABS)
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