Stamatescu Gabriela
Medical reviewer at Montreal Health Innovations - Coordinating Center - MHICC- Claim this Profile
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French, English, Romanian -
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Bio
Joanne Gavalakis
As a Medical Reviewer Gabriela is providing strong support to the project management team. Gabriela is always eager to learn and implement any new regulation to the numerous national and international clinical studies that she is responsible for. Gabriela is collaborative and engaging.
Ryan Catherine Breithaupt
C'était un plaisir de travailler avec Gabriela. Elle a énormément d'expertise, de professionalisme et d'esprit d'équipe. Elle cherche constamment à aider les autres et son dévouement envers sa profession est claire. Elle est minutieuse et soucieuse de la qualité. Elle sera un atout dans n'importe quelle équipe !
Joanne Gavalakis
As a Medical Reviewer Gabriela is providing strong support to the project management team. Gabriela is always eager to learn and implement any new regulation to the numerous national and international clinical studies that she is responsible for. Gabriela is collaborative and engaging.
Ryan Catherine Breithaupt
C'était un plaisir de travailler avec Gabriela. Elle a énormément d'expertise, de professionalisme et d'esprit d'équipe. Elle cherche constamment à aider les autres et son dévouement envers sa profession est claire. Elle est minutieuse et soucieuse de la qualité. Elle sera un atout dans n'importe quelle équipe !
Joanne Gavalakis
As a Medical Reviewer Gabriela is providing strong support to the project management team. Gabriela is always eager to learn and implement any new regulation to the numerous national and international clinical studies that she is responsible for. Gabriela is collaborative and engaging.
Ryan Catherine Breithaupt
C'était un plaisir de travailler avec Gabriela. Elle a énormément d'expertise, de professionalisme et d'esprit d'équipe. Elle cherche constamment à aider les autres et son dévouement envers sa profession est claire. Elle est minutieuse et soucieuse de la qualité. Elle sera un atout dans n'importe quelle équipe !
Joanne Gavalakis
As a Medical Reviewer Gabriela is providing strong support to the project management team. Gabriela is always eager to learn and implement any new regulation to the numerous national and international clinical studies that she is responsible for. Gabriela is collaborative and engaging.
Ryan Catherine Breithaupt
C'était un plaisir de travailler avec Gabriela. Elle a énormément d'expertise, de professionalisme et d'esprit d'équipe. Elle cherche constamment à aider les autres et son dévouement envers sa profession est claire. Elle est minutieuse et soucieuse de la qualité. Elle sera un atout dans n'importe quelle équipe !
Experience
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Montreal Health Innovations Coordinating Center (MHICC)
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Canada
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Medical reviewer
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Aug 2011 - Present
As a medical reviewer I have the responsibility to: - review and provide input about the clinical study protocol - review and provide input on other study related documents (eCRF, completion guidelines, adverse events and endpoints completion guidelines, data management plan) - review the patients' eCRF (InForm) data and the documents related to the reported events - generate DSMB and CEC charters and follow-ups to ensure committee composition completed - provide training and assistance to the members of the adjudication committees (chairman and the independent reviewers) - manage the adjudication committees and ensure that all potential endpoints/events are adjudicated, as specified in the clinical study protocols - ensure medical consistency, accuracy, and validity of the clinical study data as per Regulatory requirements and internal SOPs - participate to the Investigators' Meetings - provide training and/or guidance to the site staff, the Clinical Research Associates and to the MHICC staff - generate the medical review plan - report SUSARs to the Regulatory Authorities within the required timelines - write narratives for SUSARs, SAEs and other adverse events, as specified in the study protocol - review and approve the medical coding. Show less
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inVentiv Health clinique
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Canada
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Quality Assurance Auditor
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Nov 2008 - Aug 2011
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Anapharm Inc.
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Montreal, Canada Area
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Screening/Selection Technician
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Aug 2007 - Nov 2008
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National Medicines Agency (Romania)
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Wellness and Fitness Services
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1 - 100 Employee
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Coordinator SPC/leaflet/labelling/publicity service and Medical Assessor
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Mar 2001 - Aug 2006
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Education
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2008 - 2012
UDEM University of Montreal
DESS, Drug development, Faculty of Pharmacy -
1991 - 1997
University of Medicine and Pharmacy ``Iùliu Hatieganu``, Cluj Napoca
Physician, Medical Field -
1987 - 1991
Stefan The Mightiest, Suceava, Romania
Highschool, Mathematics and Physics
Community
