CV créé le :
27/10/2023
CV modifié le :
27/04/2024
Dernière connexion :
27/04/2024
Coordonnées
*************
************
Adresse :
*** *** ***********
Aubervilliers (93300)
Email :
************@*******.**
Port. :
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Attaché de Recherche Clinique, Sénior
Référence : 688426
Expériences Professionnelles
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juil. 2022
aujourd'hui
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Freelance Study Coordinator
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Actalent on behalf IQVIA
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July 2022- Today’s Freelance Study coordinator –Actalent on behalf IQVIA, Paris
-Follow-up of a phase III study in psychiatry (Schizophrenia)
• Performing site management,
• Performing data entry,
• Queries resolution,
• AE and concomitant treatment reconciliation,
• Electronic CRF.
Therapeutic area: CNS.
Site number: 1, France.
Patient number: 1.
-Follow-up of a phase III study in oncology (Lymphoma)
• Performing site management,
• Performing data entry,
• Queries resolution,
• AE and concomitant treatment reconciliation,
• Electronic CRF.
Therapeutic area: Oncology.
Site number: 2, France.
Patient number: 8.
-Follow-up of a phase I/II study in oncology (Lymphoma)
• Performing site management,
• Performing data entry,
• Queries resolution,
• AE and concomitant treatment reconciliation,
• Electronic CRF.
Therapeutic area: Oncology.
Site number: 1, France.
Patient number: 12.
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mai 2022
juin 2022
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Clinical Research Associate -Euraxi Pharma, Joué Les Tours
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*Follow-up of a phase IV study in oncology (Breast cancer)
* Performing monitoring visit.
* Electronic CRF.
Therapeutic area: Oncology.
Site number: 2, France.
Patient number: 47.
*Follow-up of a phase IV study in oncology (Urothelial carcinoma)
* Performing monitoring visit.
* Electronic CRF.
Therapeutic area: Oncology.
Site number: 5, France.
Patient number: 60.
*Follow-up of a phase IV study in oncology (Lymphoma)
* Performing monitoring visit.
* Electronic CRF.
Therapeutic area: Oncology.
Site number: 1, France.
Patient number: 8.
*Follow-up of a phase IV study in hematology (ASMD disease)
* Performing monitoring visit.
* Electronic CRF.
Therapeutic area: Hematology.
Site number: 5, France.
Patient number: 30.
*Follow-up of a phase IV study in hematology (Gaucher disease)
* Performing site initiation phone call.
* Electronic CRF.
Therapeutic area: Hematology.
Site number: 5, France.
Patient number:60.
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juil. 2021
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Today's
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Paris
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*Follow-up of a phase III study in diabetology.
* Performing monitoring visit.
* Electronic CRF.
Therapeutic area: Diabetology.
Site number: 1, France.
Patient number: 18.
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juin 2021
avr. 2022
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Clinical Research Associate
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ConvaTec Laboratories, La Garenne-Colombes
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*Follow-up of an observational study in continence care
* Performing site initiation visit.
* Performing monitoring visit.
* Regulatory submissions
* Electronic CRF.
Therapeutic area: Urology.
Site number: 9, France.
Patient number:160.
*Follow-up of an observational study in cicatrization
* Performing site initiation visit
* Management of the Investigators Meeting
* Performing monitoring visit.
* Regulatory submissions
* Electronic CRF.
Therapeutic area: Advanced Wound Care.
Site number: 5, France.
Patient number:90.
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févr. 2019
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Study coordinator - Hospital Necker
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*Follow-up of an observational study in Alport syndrome
* Performing data entry in an electronic e-CRF.
* Electronic CRF.
Therapeutic area: Nephrology.
Site number: 40, France.
Patient number:90.
*Follow-up of an observational study in cystinosis
* Performing data entry in an electronic e-CRF.
* Electronic CRF.
Therapeutic area: Nephrology.
Site number: 40, France.
Patient number:90.
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oct. 2018
déc. 2018
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Interim period - Polyvalent employee
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Alliance emploi
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* Postal tri selection
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déc. 2016
févr. 2017
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Freelance Senior Coordinator Clinical Research Associate
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GALENUS., Basel
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*Follow-up of a global national phase IV epilepsy study for SANOFI.
* Performing On site site monitoring and close-out visits. Producing comprehensive
monitoring visit and close-out reports.
* Electronic CRF.
Therapeutic area: Epilepsy.
Site number: 3, France.
Patient number: 160.
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août 2012
mai 2015
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Senior Coordinator Clinical Research Associate
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BIOPROJET Laboratory, Paris
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*Follow-up of an international phase III narcolepsy study.
* Performing On site site monitoring and close-out visits. Producing comprehensive
monitoring and close-out visit reports.
* DSMB Management,
* Investigator payment,
* Review of the Statistical Analyses Report and clinical study report,
* Regulatory submission,
* Electronic CRF,
* Audit followed: No major findings.
Therapeutic area: Central Nervous System.
Site number: 8, France and Hungary.
Patient number: 102.
*Follow-up of an international phase II smoking cessation study.
* Study start-up phase,
* Regulatory submission,
* DSMB management,
* CRO management (Co-monitoring visits, mentoring of Junior CRA, answering to daily
contact, contract management),
* Preparation of the ICF, CRF, summary,
* Review of the monitoring plan and the data management plan,
* Electronic CRF.
Therapeutic area: Addictology.
Site number: 19, France, Poland and Republic Czech.
Patient number expected: 250
*Follow-up of an international phase II cocaine cessation study.
* Study start-up phase,
* Regulatory submission,
* DSMB management,
* CRO management (Co-monitoring visits, mentoring of Junior CRA, answering to daily
contact, contract management),
* Preparation of the ICF, CRF, summary,
* Review of the monitoring plan and the data management plan,
* Electronic CRF.
Therapeutic area: Addictology.
Site number: 3, Netherlands and Belgium.
Patient number expected: 194
*Follow-up of an international phase II cocaine cessation study.
* Study start-up phase,
* Regulatory submission,
* DSMB management,
* CRO management (Co-monitoring visits, mentoring of Junior CRA, answering to daily
contact, contract management),
* Preparation of the ICF, CRF, summary,
* Review of the monitoring plan and the data management plan,
* Electronic CRF.
Therapeutic area: Addictology.
Site number: 3, United-States.
Patient number expected: 250
*Follow-up of an international phase II restless leg syndrome study.
* Study start-up phase.
* DSMB management,
* CRO management (Co-monitoring visits, mentoring of Junior CRA, answering to daily
contact, contract management),
* Preparation of the ICF, CRF, summary,
* Review of the monitoring plan and the data management plan,
* Electronic CRF.
Therapeutic area: Central Nervous System.
Site number: 3, France.
Patient number expected: 91
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juil. 2012
sept. 2015
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Freelance Senior Coordinator Clinical Research Associate
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ADENOBIO N. V., Paris
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*Follow-up of a global national phase II ischemic heart disease study.
* Performing On site site monitoring and close-out visits. Producing comprehensive
monitoring and close-out visit reports.
* Review of the Statistical Analyses Report and clinical study report
* Regulatory submission,
* Paper CRF.
Therapeutic area: Cardiovascular disease.
Site number: 1, France.
Patient number: 60.
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déc. 2010
juil. 2011
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Clinical Research Associate
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CRO Quintiles, Levallois-Perret
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*Follow-up of a global national phase IV axial spondyloarthritis study for PFIZER.
* Performing On site site selection visits and site initiation visit. Producing
comprehensive selection visit reports.
* Paper CRF.
Therapeutic area: Rheumatology.
Site number: 15
* Follow-up of a global international phase IV HIV-1 study for PFIZER.
* Submission to the ethic committee and the regulatory authorities. Preparation of the
summary and the ICF.
* Performing On site site selection visit.
* Electronic CRF.
Therapeutic area: Infectious diseases.
Site number: 6
*Follow-up of a global international phase IV neuropathic low back pain study for PFIZER.
* Submission to the ethic committee and the regulatory authorities. Preparation of the
summary and the ICF.
* Performing On site site selection visit.
* Paper CRF.
Therapeutic area: Rheumatology.
Site number: 12
*Follow-up of a global international phase IV acute myocardial infarction for PFIZER.
* Performing On site site initiation visit.
* Electronic CRF.
Therapeutic area: Cardiovascular disease.
Site number: 6.
*Follow-up of a global international phase IV acute leukemia study for PFIZER.
* Performing On site site initiation visit.
* Electronic CRF.
Therapeutic area: Oncology.
Site number: 12.
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juin 2008
nov. 2010
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Clinical research associate
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CRO OmnicareCR, Gentilly
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*Follow-up of a national phase II study for SANOFI-PASTEUR
* On site Monitoring visits of a phase II rabies vaccination study.
* Collection of essential document.
* SAE report form checking.
* Queries resolution.
Therapeutic area: Immunization/vaccines.
Site number: 3
Patient number: 300
* Follow-up of a national phase II study for SANOFI PASTEUR
* On site Site initiation and monitoring visits of a phase II A/H1N1 vaccination study.
* Collection of essential document.
* SAE report form checking.
* Queries resolution.
* Audit followed: No major findings.
Therapeutic area: Immunization/vaccines.
Site number: 3
Patient number: 300
* Follow-up of a national phase III study for SANOFI PASTEUR.
* On site Monitoring and close-out visits of a phase III flu vaccination study.
* Collection of essential document.
* SAE report form checking.
* Queries resolution.
Therapeutic area: Immunization/vaccines.
Site number: 3
Patient number: 100
* In service at BAXTER, Maurepas (during 9 months between June 2008 and March 2009).
* Identification of potential investigational sites,
* On site Selection, initiation, monitoring and close-out visits of a phase III
parenteral nutrition study taking part in France and in Belgium,
* Within international, the collection of high quality critical documents and
completion of ethics committee and regulatory submissions in association with
Investigators Services,
* Administrative follow-up, logistics of treatments and materials of the study,
* Queries resolution.
Therapeutic area: Pediatrics Gastroenterology.
Site number: 8
Patient number: 90
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oct. 2006
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Assistant to project leader
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Marc2007
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* Qualification of files resulting from investigations by adding knew information,
* Proof reading to check for consistency.
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janv. 2002
sept. 2006
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Salesman - Art gallery of Decorations and Antiquities, Paris
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* Reception of international customer,
* Management of the store,
* Organization of transport and storage logistics.
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juil. 1999
nov. 2001
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Computer engineer - Company Transiciel, Saint-Cloud
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* Administration of technical plateforms « receipt and qualification »,
* Follow-up of compilations,
* Management of the incidents within the support team.
In service at : Exane, ParisbourseSA-Euronext, Bouygues Télécom, GIE cartes bancaires.
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janv. 1998
juin 1999
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Military period
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Institut de Recherche Criminelle de Gendarmerie Nationale - Laboratoire de microanalyse, Rosny-sous-Bois
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Activity: Participation in 4 forensics investigations using the techniques of scanning
microscopy, of ICP- plasma torch spectrometry, and IR spectrometry.
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sept. 1997
déc. 1997
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Training engineer
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Délégation Générale de l'Armement, Arcueil
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Mission: Study of optical and chemical characteristics of molecules presenting of the
properties useful for optical limitation.
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janv. 1995
août 1997
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Scientific animator - In service at : UCPA, Cité des sciences et de l'industrie, Musée de l'air et de l'espace du Bourget
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du Bourget, ANSTJ, Aloïse, Planète-sciences, Société française de chimie, Association
petits débrouillards, Ateliers bleus de la ville de Paris...
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oct. 1994
juil. 1995
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Engineer of studies
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ESPCI, Paris
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Master's degree training period: Study of complex of inclusion cyclodextrin - aromatic
ketones substituted by solid NMR spectrometry.
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mars 1994
juin 1994
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Training chemist - UPMC, Paris
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Memoir: Followed desalumination of zeolite LZY64 by solid NMR spectrometry.
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CRO Clinicalland, Paris
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* Follow-up of a national renal failure phase IV study for SHIRE.
* On site monitoring visits and close-out visits,
* Investigators payment,
* Update of the administrative documents (TMF, SOP),
* SAE report form checking.
* Paper CRF
Therapeutics area: nephrology
Site number: 50.
Patient number: 400.
* Follow-up of an international phase IV study dealing with the use of a hemostatic swab
in surgery for NYCOMED.
* On site monitoring visits and close-out visits,
* Management of investigators and hospital contract negotiation and payment,
* Update of the administrative documents (TMF, SOP),
* SAE report form checking.
* Paper CRF
Therapeutics area: surgery
Site number: 50.
Patient number: 400.
* Follow-up of a national phase III study dealing the acne treatment for URIAGE.
* On site site selection visit, site initiation, monitoring visits and close-out visits,
* Management of investigators and hospital contract negotiation and payment,
* Submission to regulatory affairs and ethics committees,
* SAE report form checking,
* Paper CRF.
Therapeutics area: dermatology
Site number: 10.
Patient number: 120.
* Feasibility study on a phase III study dealing with chronic obstructive
bronchopneumopathy for BAYER.
* On site pre-study visit.
* Essential documents collection.
Therapeutics area: pneumology.
Site number: 30.
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Diplômes et formations
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juil. 2019
nov. 2019
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Consultant collaborative office 365 microsoft training program
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Eliadys academy-Rueil-Malmaison
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juin 2007
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Clinical research associate training program
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April-June; Institut Léonard De Vinci - GEMS - Pôle universitaire La Défense
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juin 1995
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DEA de chimie appliquée et genie des procedes industriels (equivalent to Master's degree in applied chemistry and industrials engineering process)
- BAC+3
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Ecole Nationale Supérieure Chimie Paris
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juin 1990
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DEUG de sciences de la nature et de la vie (equivalent to second year of university in natural and life sciences)
- BAC+2
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Faculté de Médecine de Bobigny
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Compétences
data management plan, Computer engineer, office 365, Microsoft office, CTMS, COMPUTER TECHNOLOGY
Compétences linguistiques
Centres d'intérêts
Running, swimming, biking, Concert, theater, exposition
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