Dr. [...] [...]

3/2004 – 1/2014

Freelancer Experiences:

Since December 2013 Oncology Phase II for colorectal cancer IV. Phase II study.
Since December 2011 project for dementia for a Phase III study. Responsible for 7 sites as Senior CRA.
From September 2008 - November 2013 Freelancer CRA working for a European Phase IV Registry (Colitis). Responsible for 40 sites in Austria and Germany.
June 2011 – November 2013 responsible CRA for a PASS Registry with indication atrial fibrillation. Full responsibility for 10 sites in Germany.

All projects with following responsibilities:
• Ethic submission, Competent Authority Notification
• Initiation Visits, Monitoring Visits, Site Closure Visits
• Query solution, AE and SAE reporting and Follow up, Drug accountability
• Annual reports to EC, Payment issues and site Management
• Creations of Newsletters.

Starting with Freelancer responsibilities in September 2008 during maternal leave with accreditation from employer for a Colitis Registry Phase IV trial.

Field Clinical Research Specialist
From January 2006 - December 2009 working as FCRS (Field Clinical Research Specialist) for a medical device company (Defibrillator and Pacemaker). The responsibility of a FCRS is similar to a Project Manager with the responsibility of creating protocols, ethic submission, audits and to control the sites to meet the ICH/GCP and ISO 14155 Guidelines and the evaluation of clinical data and publication. Full Responsibility for 10 ongoing trials (Phase III and IV) in the south west part of Germany.

Additional Responsibilities in detail
• Overall Project Management
• Creation of study documents (CRF, Patient Information Sheet and Informed Consent forms, diary, SDV checklists etc.)
• Feasibility and site selection
• Organize and negotiate contracts with hospitals and Investigators
• Organisation of Investigator Meetings
• Device accountability


Junior CRA
From March 2004 until December 2005 working for a Clinical Research Organisation as a CRA in a large multi-national study (phase II) including over 1000 patients across Europe and Canada.
Has experience working in the area of CABG trials. Since July 2004 has been working with full monitoring responsibilities for one site and as a co-monitor for two sites. Since December 2004 working in a worldwide phase III study with 850 sites and 13.000 patients with acute coronary syndrome and responsibility for 7 sites across Germany.

Responsibilities are summarised below
• Attendance at Investigator Meetings
• Site Selection Visits
• Initiation Visits
• Monitoring Visits
• Query handling
• Closure Visits