CL I Senior & Lead CRA

• Klinische Monitor (CRA)
• Medizinforschung

Profile as Senior Clinical Research Associate (CRA) and Lead CRA

I have been working for the pharmaceutical industry as well as for CROs as a Senior Clinical Research Associate and Lead CRA for 15 years. Before this profession I have worked in clinics and in 3rd party projects at the university.
I cover all project activities related to Monitoring of Clinical Trials. My strength is proactive site and project management from the beginning to the completion together with the investigators, the CRAs, the project leader and the functional leads from Regulatory, Safety, Data management, Statistics and external contractors/vendors.
During the planning phase, I develop the Monitoring plan and give support in developing and reviewing Monitoring forms and tools from the first draft through the final version. I provide administrative support to meet the study specific requirements of the client as well as the standards and expectations of the Regulatory Authorities and Ethics Committees.
In the execution phase I lead the Monitoring team and coordinate the international Monitoring activities. I provide direction and guidance to the Monitoring team and mentor less experienced CRAs. I train the CRAs on the Monitoring tasks as outlined in the Monitoring plan. I communicate between the Monitoring team and the project and functional leaders with focus on escalation processes to raise project issues to the next management level and higher authorities for timely resolution.
In the close-out phase I cooperate with Project Leader and Monitoring Team to close-out the sites and collate the Trial Master File according to the standard operation procedures in place.
I have gained therapeutic experience in dermatology, oncology, nephrology, cardiology, neurology, psychiatry, pulmonology, urology and immunology.
I have written the Monitoring plans for an SLE study, an onychomycosis study and a CINV study.
I have successfully coordinated a submission of an innovative low radiation CT protocol to the German radiation board for a CF paediatric trial together with sites and sponsor.
I have attended several audits and an EMEA inspection.

I hold a M.A. in Phonetics from the Ludwig-Maximilians-University in Munich and I am a certified dietician.


Professional Experience

OCT 2002 MAR 2010 KENDLE GMBH, MUNICH, GERMANY
Senior CRA und Lead CRA, Clinical Operations, On-site Monitoring
MAY 1998 AUG 2002 LUNDBECK GESMBH, VIENNA, AUSTRIA
Senior CRA for Austria
FEB 1997 APR 1998 IBRD ROSTRUM, WUPPERTAL, GERMANY
Senior CRA for Austria and Switzerland
MAR 1995 DEC 1996 IMMUNO AG, VIENNA, AUSTRIA
CRA
JAN 1994 AUG 1994 VERLA PHARM, TUTZING, GERMANY
CRA
JAN 1992 DEC 1993 STATICON GMBH, PLANEGG, GERMANY
Clinical Data Manager for Data Entry
MAR 1990 SEP 1991 PSYCHIATRIC CLINIC AND POLICLINIC OF THE UNIVERSITY OF MUNICH
Project assistant for an epidemiologic study of the elderly
Münchner Hochbetagten-Studie


Therapeutic Experience

CARDIOLOGY Cardiovascular - Arterial Hypertension, Phase 3
CNS NEUROLOGY Epilepsy, Phase 3
Parkinsons Disease, Phase 3
Alzheimers Disease, Phase 3
CNS PSYCHIATRY Schizophrenia, Phase 4
Major Depression, Phase 3
CNS - WOMENS HEALTH Menstrual Migraine, Phase 3
DERMATOLOGY Onychomycosis, Phase 3
IMMUNOLOGY Immunglobulins in the Prevention of Infections, Phase 3
Systemic Lupus Erythematosus SLE, Phase 2
Rheumatoid Arthritis, Phase 2
Grass Pollen Allergy, Phase 3
Gammaglobulins for Low Birth Weight Infants, Phase 4
NEPHROLOGY Type II Diabetes in Dialysis patients, Phase 4
Chronic Kidney Disease - Endstage Renal Disease, Phase 3
Cardiovascular Complications in Dialysis patients, Phase 3
ONCOLOGY Chemotherapy Induced Nausea and Vomiting CINV, Phase 3
PNEUMOLOGY Cystic Fibrosis Phase 3
UROLOGY Sexual Dysfunction PE, Phase 3

Forschung & Wissenschaft
- Chemie (allg.)
- Pharmazie (allg.)

Phonetik und Sprachliche Kommunikation, Ernährungslehre/Diätetik