Senior CRA

Freelance CRA seit 2004

• Forschung & Entwicklung
• Medizinforschung

Ich habe meinen Lebenslauf eingefügt.

Curriculum Vitae



Current position:


March 2009 to March 2015
Freelance Senior Clinical Research Associate

Education and academic degrees:


Jul 1983 to Sep 1985 State educational establishment for Medical Technical Assistants, State Registered MTA

Jul 1989 to Jun 1990 Foreign trade agent, Brazil

Aug 1990 to Jun 1991 Advanced technical college entrance qualification, technical college for social affairs, Kaiserslautern

Oct 1991 to Jan 1995 Study of social education, College, Frankfurt/Main

Feb 1995 to Dec 1997 Maternity leave


Professional experience:

Apr 2015 to present Senior Clinical Research Associate for Tempo-Team

Dec 2014 to Mar 2015 Senior Clinical Research Associate for Docs

Mar 2012 to Dec 2014 Senior Clinical Research Associate for Covance

Dec 2010 to Feb 2012 Senior Clinical Research Associate for HZM-Pharmaservice GmbH (Germany)

Mar 2009 to Aug 2011 Senior Clinical Research Associate for Pharmaprojekthaus GmbH & Co. Kg (Germany)

Jul 2007 to Feb 2009


Sep 2004 to Jun 2007
Clinical Research Associate
Health Research Services Ltd., St. Leon-Rot (Germany)

Clinical Research Associate
Coordination Centre for Clinical Trials, Medical School of the University Mainz, Mainz (Germany)

Jan 1998 to Sep 2004
Study Nurse
Institut für klinische Pharmakologie Prof. Dr. Lücker GmbH,
Grünstadt (Germany)
Jan 1986 to Jun 1989

MTA
Coagulation Laboratory
Städtisches Krankenhaus Kaiserslautern, Kaiserslautern (Germany)



Clinical trial experience:


Senior Clinical Research Oncology NSCLC
Associate
Tempo-Team A Randomized, Double Blind, Multicenter, Phase III Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Responsibilities: responsibility for 3 German sites, support to project leader, review of documents.

Oncology NSCLC
A Randomized Open Label, Multicenter, Phase III Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator’s Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers.
Responsibilities: responsibility for 1 German site, support to project leader, review of documents.

Oncology Metastatic Colorectal Cancer
A Randomized, Blinded, Multicenter, Phase II Study Comparing Veliparib Plus FOLFIRI+/- Bevacimumab Versus Placebo Plus FOLFIRI +/- Bevacimumab in Previously Untreated Metastatic Colorectal Cancer.
Responsibilities: responsibility for 2 German sites, support to project leader, review of documents.




Senior Clinical Research Rheumatoid Arthritis
Associate
Covance A phase IV, multicenter, randomized, double-blind parallel-group study, dose tapering of Adalimumab controlled by withdrawal, in subjects with rheumatoid arthritis in stable clinical remission.
Responsibilities: Pre-Study responsibility for 3 Austrian sites, support to project leader, review of documents.


A phase II randomized double-blind, placebo-controlled trial of radium-223 dichlorid versus placebo when administered to HER2 negative hormone receptor positive breast cancer with bone metastases treated with the standard of care treatment exemestane and everolimus
Responsibilities: Pre-Study responsibility for 17 German sites, support to project leader, review of documents.




A phase1b/2Study with Gemcitabine and LY2157299 for patients with Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2).
Responsibilities: Full monitoring responsibility for 5 German sites, support to project leader, review of documents.


Senior Clinical Research Oncology CLL
Associate
HZM Pharmaservice,
Covance An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 and
Chlorambucil (GClb), rituximab and chlorambucil (RClb) or chloramucil (Clb) alone in previously untreated CLL patients with comorbidities.
Responsibilities: Full monitoring responsibility for 17 German sites, support to project leader, review of documents.



Senior Clinical Research Neovascular AMD
Clinical Research Associate
Kendle GmbH
Munich (Germany)







A randomized double masked, active controlled, phase III study of efficacy, safety, and tolerability of repeated doses of intravitreal VEGF Trap-Eye in subjects with neovascular Age-related Macular Degeneration (AMD)
Responsibilities: Full monitoring responsibility for 2 German sites, support to project leader, review of study documents.






Senior Clinical Research Associate
PharmaProjekthaus GmbH & Co. KG
Frankfurt am Main
(Germany)










HIV Infection

Phase IIIb, open trial, to compare the virological efficacy and safety of two drug classes (nonnucleoside reverse transcriptase inhibitor [NNRTI] and protease Inhibitor) in treatment-naïve patients.
Study Drug: NNRTI
Full monitoring responsibility for 16 German sites.
Clinical Research Associate
Health Research Services Ltd., St. Leon-Rot (Germany)




HIV Infection

Phase IIIb, open trial, to compare the virological efficacy and safety of two drug classes (nonnucleoside reverse transcriptase inhibitor [NNRTI] and protease Inhibitor) in treatment-naïve patients.
Study Drug: NNRTI
Full monitoring responsibility for 5 German sites.









Clinical Research Associate
Coordination centre for Clinical Trials, Medical School of the University Mainz (Germany)




















HIV Infection
Phase IV, retrospective toxicogenomic case-control study, to identify unique genetic polymorphism.
Study Drug: NNRTI
Full monitoring responsibility for 3 German sites including close-out visits.



Focal Epilepsy

IIT: Multicenter, double blind, randomized, phase IV clinical trial comparing the safety, tolerability and efficacy of levetriacetam versus lamotrigine and carbamazepine in the oral antiepileptic therapy of newly diagnosed elderly patients with focal epilepsy. Responsibilities: Full monitoring responsibility for 16 German sites, initiation visits, translation and review of study documents, prepare presentation for investigator meeting, support to project leader, review of study documents.



Type 2 Diabetes Mellitus and Depression
IIT: Cognitive behavioral therapy vs. sertraline
in patients with depression and poorly controlled diabetes mellitus: a randomized controlled trial – Diabetes and Depression study, 46 centers in Germany
Responsibilities: Initiation visits, full monitoring responsibility for 23 German sites, support to project leader, review of study documents.







Coronary artery disease
IIT: Impact of 12 weeks oral niacin on endothelial function, lipid composition and cardiovascular biomarkers in patients with coronary artery disease: A prospective, randomized, double blind, placebo-controlled, monocentric clinical trial of Phase IV study.
Responsibilities: Initiation visits, full monitoring responsibility for 1 German site, support to project leader, review of study documents, close out visit.



Vaccine Prophylaxis in children
Phase III, double blind, randomized, multicenter, clinical study to assess the safety and immunogenicity of vaccine when given as booster dose to healthy school children and adolescents (9-13 years old), previously vaccinated with a fifth consecutive dose of a cellular pertussis-containing vaccine.
Responsibilities: Initiation visits, full monitoring responsibility for 1 German site, support to project leader, review of study documents.



Acupuncture in the indications: Headache, Migraine, Gonarthrosis and Chronic sacroiliac pain
Health insurance: A multicenter randomized controlled study.
Responsibilities: Full monitoring responsibility for 5 German sites, support to project leader, review of study documents.



Chronic active ulcerative colitis
A multicenter, double blind, randomized, placebo controlled investigation of long-term safety and efficacy of LCAP (medical device) in patients with refractory, chronic or active ulcerative colitis.
Responsibilities: Initiation visits, full monitoring responsibility for 3 German sites, support to project leader, review of study documents.



Rehydration in infants with infectious enteritis
Multicenter, double blind, randomized phase IV study. Effect of Dimenhydrinat supplement. vs. placebo to rehydration of infants with infectious enteritis.
Responsibilities: Initiation visits, full monitoring responsibility for 1 German site, support to project leader, review of study documents, close out visit.



Chronic Hepatitis
Multicenter, randomized phase III study. Three Regimes of PEG-Intron/Ribavirin- treatments in chronic hepatitis c, genotype 2 or 3, in previously untreated patients.
Responsibilities: Full monitoring responsibility for 3 German sites, support to project leader, review of study documents.



Study Nurse
Institut für klinische Pharmakologie, Prof. Dr. Lücker GmbH
Grünstadt (Germany)



Different Indications
Experience in more than 100 phase.I + IIa studies with different indications
Responsibilities: Study nurse
Other special interests, language skills:

German, native
English, fluent
Proficient with MS Office programs, eCRF: Oracle Clinical ,Rave, Inform, Macro


Employee Signature:
Date: 16-Juli-2015