Marielle FABRE

En résumé

Entreprises

• RPS Research France S.A.S - Senior Clinical Research Associate

  2010 - maintenant * Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner. ;
  * Conduct study feasibility and site selection activities. ;
  * Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities. ;
  * Assist with investigator meeting activities including organization, preparation and attendance ;
  * Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
  * Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
  * Establish and maintain good rapport with study sites. ;
  * Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
  * Coordinate timely shipment of clinical supplies and study drug to sites.
  * Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
  * Maintain adequate site tracking records ;
  * Follow up of drug safety issues and safety reports in timely manner, if applicable
  * Communicate site study issues, concerns, and progress Project Manager, Clinical Team Lead and Clinical Research Manager accordingly
  * Assist with data query form (incl. query process) ;
  * Develop and implementation of corrective actions when appropriate ;
  * Prepare /review all patients tracking records ;
  * Input and maintain study information concerning subject status of financial reimbursement to sites.
  * Conduct and assist with administrative activities as a member of the project team. ;

• PFIZER - Clinical Research Associate - Home

  Paris 2004 - 2009 Clinical Research Associate - Home based - Southwest-
  * Clinical Study Set-up
  * Site Initiation Visit
  * Site Monitoring Visit
  * Site Close out Visit
  * Study treatment management
  * Investigators Meeting
  * Tracking patient data ;
  * Reporting to the sponsor ;
  * Archiving of TMF ;

• PHARMACIA - Clinical Research Associate - Home

  2001 - 2004 Clinical Research Associate - Home based - Southwest -
  * Clinical Study Set-up
  * Site Initiation Visit
  * Site Monitoring Visit
  * Site Close out Visit
  * Study treatment management
  * Investigators Meeting
  * Tracking patient data ;
  * Reporting to the sponsor ;
  * Archiving of TMF ;

• GLAXOWELLCOME - Clinical Research Associate - Home

  1997 - 2001 * Clinical Study Set-up
  * Site Initiation Visit
  * Site Monitoring Visit
  * Site Close out Visit
  * Study treatment management
  * Investigators Meeting
  * Tracking patient data ;
  * Reporting to the sponsor ;
  * Archiving of TMF ;

• GLAXOWELLCOME - Clinical Research Associate

  1993 - 1997 * Clinical Study Set-up
  * Site Initiation Visit
  * Site Monitoring Visit
  * Site Close out Visit
  * Study treatment management
  * Investigators Meeting
  * Tracking patient data ;
  * Reporting to the sponsor ;
  * Archiving of TMF ;

• GLAXO - Medical Delegate

  1990 - 1993 * Deliver Medical Information to the GP (gastro- enterology)
  * Organize specialized medical staffs to improve the diagnostic and the minimum fare of the asthmatic patients.
  * Meet specialized medical staffs in pneumology
  
  THERAPEUTIC AREA EXPERIENCE Phase 1 to Phase 3 in the following areas:
  Oncology: Breast, Kidney, Lung, Liver, Brain, Colorectal, Prostate
  Onco heamatology: Multiple Myeloma
  Cardiology: CHF, Smoking Cessation.
  NCS: Alzheimer, Epilepsy, Bipolar Disorders, Migraines
  Rheumatology : Arthrosis, Rheumatoid Arthritis
  Pneumology: Asthma, COPB , smoking cessation
  Endocrinology: Growth Hormone (Pediatric), Early SGA, Diabetes

Formations

• Pierre & Marie Curie University + Medecine University Xavier Bichat

  Paris 1988 - 1989 Post-Graduate Certificate
  
  Endocrinology: Cellular, Molecular & Metabolic Aspects

• Université Paris 6 Pierre Et Marie Curie UPMC

  Paris 1987 - 1988 Masters Degree
  
  Biology & Physiology

• Université Paris 6 Pierre Et Marie Curie UPMC

  Paris 1986 - 1987 Bachelors Degree
  
  Biology & Physiology

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