Monitoring klinischer Studien

10/2000 – 12/2011

Involved as CRA / study assistant in about 65 phase I/II studies and 2 phase in patients with liver cirrhosis, renal impairment, hypertension, hepatitis C, diabetes mellitus Type subjects 1 and 2, erectile dysfunction, benign prostatic hyperplasia or chronic obstructive pulmonal disease as well as in vaccination studies in healthy.
The activities include the acquisition of studies, communication and meetings with sponsors, providing the study documents for the permission of the studies at the ethics commission of the national physician chamber, patient recruitment, study-preparation, communication with study laboratory, authorities and monitors. Study execution in practice, inclusive laboratory activities such as blood collection, letters of EKG`s, inoculation and similar medical activities, entries of data in CRF's and e-CRF's, monitoring of parallel studies, intermediate evaluations up to close out visits and study conclusion with notices of departure at the authorities and following archiving of the study documents.