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inVentiv Health Clinical
- Clinical Trial Assistant
Nanterre
2014 - maintenant
inVentiv Health Clinical, providing services to Novartis Oncology.
Partners with the Project Managers and the Clinical Research Associates.
Performs logistical, clerical and administrative tasks.
Ensures the current versions of the required trial documents are provided to the investigational sites within required timeframes
Supports the CRA/PM in collecting, tracking, performing quality check and maintaining all documents throughout the trial and post-trial in both eTMF and paper files.
Performs the customization, shipment, tracking and collection of contracts, financial disclosure forms.
Scans and uploads essential study documents into the eTMF.
Prepares TMF archiving.
Receives and handles with study drugs supply requests.
Receives and transfers SAE forms from the PV department to the CRAs.
Contributes to process improvement and contributes to the optimization of daily processes.
Complies with relevant training requirements.
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Quintiles
- Senior Clinical Trial Assistant
Durham
2013 - 2014
Quintiles, providing services to Janssen, Pharmaceutical Companies of Johnson and Johnson.
Therapeutic areas: Diabetology, Infectiology, Oncology, Hematology.
Partnered with the Project Managers and the Clinical Research Associates.
Performed logistical, clerical and administrative tasks.
Supported the local study team in performing site feasibility.
In liaison with the PM, ensured current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
Supported the PM and the CRA, in providing the current and complete documents requested by the Ethics Committees (CPP) and the Competent Authorities (ANSM, CNOM, CDOI).
Supported the CRA/PM in collecting, tracking and maintaining all documents throughout the trial and post-trial in both eTMF and paper files.
In charge of the customization, shipment, tracking and collection of confidentiality disclosure agreements, contracts, financial disclosure forms.
Contributed to process improvement and contributes to optimization of daily processes.
Coached and mentored to a less experienced CTA.
Complied with relevant training requirements.
Supported the Project Manager in charge of Investigator-Initiated Studies.
Partnered with the Project Manager in charge of an Early Access Program in oncology-hematology.
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SGS Life Science Services
- Clinical Research Associate
Arcueil
2011 - 2013
Performed study initiation, monitoring and close-out of Phase I studies in healthy subjects.
Wrote visit reports (initiation, monitoring, close-out).
Defined and wrote the Monitoring Guidelines and Monitoring Plan.
Performed source data verification and source data review.
Reviewed study-related documents (protocols, volunteer’s informed consent forms, case report forms, etc.).
Checked the process of Phase I studies, in accordance with the Good Clinical Practice, the local regulatory requirements and the study protocols.
Drug accountability.
Collaborated with both the Investigator Site and the Pharmaceutical Laboratories (Sponsors).
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SGS Life Science Services
- Clinical Trial Assistant
Arcueil
2008 - 2011
Supported the Investigators, the Project Managers and the Clinical Research Associates, within a Phase I Clinical Research Organisation.
Supported the PM in the preparation of the pieces for submission to the Ethics Committees.
Tracked, distributed, filed and archived the study-related documents in the Trial Master Files.
Performed logistical and administrative tasks.
Managed the shipments of documents and materials to the Sponsors and subcontractors.
Coached and mentored to less experienced CTAs.
Translated documents (French>English).
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Pénélope, en prestation au Crédit Agricole Asset Management
- Receptionist
Paris
2007 - 2008
Physical and telephone reception, dispatching of couriers, management and guidance of visitors, clients, couriers, taxi.
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Service Public Fédéral Justice
- Translator
2007 - 2007
Translation Department.
Legal and administrative files, articles, from Dutch and English to French, and from French to English.
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Service Public Fédéral Finances
- Translator trainee
2006 - 2006
Translation Department.
Legal, administrative, financial and economic files, from Dutch and English to French, and from French to English.
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Quick Restaurants
- Polyvalent crew member
LA PLAINE SAINT DENIS
2002 - 2003
Client service, cashier, preparation and cleaning of the restaurant and the counter.
