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