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INC Research
- Senior CRA
2016 - maintenant
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INC Research
- CRA III
2014 - maintenant
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Https://alautregoutdumonde.blogspot.com
- Sabbatical Leave
2013 - 2014
6 months travel around Pacific Asia and Australia
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PAREXEL International
- CRA II
Paris
2012 - 2013
Therapeutic Area Experience
Ophthalmology, Rheumatology, Urology (Phase II, III and IV)
Responsibility
- Qualification, Initiation, Monitoring, Close-out visits
- Management of clinical trial treatment (sending, accountability, storage) and site material
- TMF collection and review
- Data query resolution
- Management and reporting of SAEs and protocol deviations
- Reports to project management and team members
- Interaction with study contacts : Investigators and site staff, Central Lab, In-House CRA, Study Start-up team, Data Management, Sponsor
- Patient data collection (eCRF)
- Administrative and financial follow up (contracts, conventions, fees)
- Patient and study documents creation
- Participation in investigator meetings (national and international)
- CRA training (co-monitoring visits)
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EZUS-APRET
- CRA
2010 - 2012
Therapeutic Area Experience
Oncology, Neurology, Cardiology, Ophthalmology, Vascular medicine (Phase II and IV)
Responsibility
- Qualification, Monitoring, Close-out visits
- Data query resolution
- Management and reporting of SAEs
- Reports to project management and team members
- Interaction with study contacts : Investigators and site staff, Sponsor, Pharmacovigilance
- Patient data collection (paper CRF)
- Administrative and financial follow up (contracts, conventions, fees)
- CRA training (co-monitoring visits)
- WHO drug coding
- Standard Operation Procedures writing
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BAYER CROPSCIENCE
- Intern R&D
Lyon
2009 - 2009
Intern R&D in BAYERCROPSCIENCE, 9 months at Plant Health department
- Cloning, recombinant protein purification and expression
- WB, enzymatic analysis
- Crops