CLINICAL RESEARCH CONSULTING
- SENIOR CLINICAL RESEARCH ASSOCIATE
maintenant
Since 2005: Freelance Clinical Research Associate
* International CRO, since January 2011, Cardiac Electrophysiology, medical devices
-Site management activities include all in house and on-site monitoring for all visit types
* International CRO, From June to October 2010, Orthopaedics, medical devices, responsible of Start-up Activities (EC/CA/CNOM/CNIL)
* International CRO, from May 2009 to June 2011, Cardiology, medical devices
-Site management activities include all in house and on-site monitoring for all visit types
* International CRO, since 2007 to April 2011, medical device in various therapeutic areas for phase II to IV studies:
-Study documents updating according to local specificities and regulation
-AFSSAPS and EC submission, Budget negotiation, CNOM submission
-Site management activities include all in house and on-site monitoring for all visit types
* Pharmaceutical Company, since 2008 to January 2011, International phase III study in aneurismal subarachnoid haemorrhage
* International CRO, since May 2009 to Feb 2010, Oncology(CLL)
-Site selection including identification and feasibility
-Study documents updating according to local specificities and regulation (Informed Consent Form, patient’s documentation)
-Performing the agreements with sites according to local specificities and regulation (investigator, institution and association contracts)
-Responsible for EC’s submission
* International CRO, since 2006 to 2007, International phase III study in Oncology (NSCLC)
-Site management activities include all in house and on-site monitoring for all visit types
* French CRO, since 2005 to 2009: National phase III and IV studies in gastroenterology (RGO), Diabetology and Pneumology (asthma),
-Site management activities include all in house and on-site monitoring for all visit types
* Pharmaceutical Company, since 2005 to 2008 International phases I /II studies in Rheumatology:
-Responsible for EC’s submission
-Site management activities include all in house and on-site monitoring for all visit types
-Study documents updating according to local specificities and regulation
-Performing the agreements with sites according to local specificities and regulation (investigator, institution and association contracts)
March 2003 to 2004: Home-based Clinical Research Associate, International CRO
- National clinical trial monitoring for a French phase III study in Cardiology (150 sites) for all visit types
June 2001 to February 2003: Clinical Trial Associate, Pharmaceutical Company, Eastern Europe countries, international phase III studies in Gynaecology, Cardiology, Endocrinology
-International clinical trial monitoring in compliance with local regulatory requirements, regulatory documents submission, financial aspects follow-up, investigator’s meeting, and audit
-Site management activities include all in house and on-site monitoring for all visit types
1999 to 2000: Clinical Research Associate, University Hospital, Clinical research centre, Haematology /Oncology
-Site management, Responsible for completing CRFs for studies in the field of CML
