-
Covance
- Clinical Research Associate, working under contract with Sanofi
Princeton
2014 - maintenant
Conducting of Site Initiation Visits, Monitoring Visits (Source Data verification and drug accountability) and Close-Out Visits in accordance with the monitoring plan, sponsor process and GCP principles.
Contribute to the success of the study:
>To ensure the respect the ICH-GCP guidelines and protect subject safety and data integrity by ensuring protocol adherence.
>To ensure the respect of the deadlines to permit the interim and final data base locks in the good time frame.
>To ensure the study’s management when there is no clinical project leader (cause of vacancy or turn over): logistical coordination to the investigator sites (to communicate guidelines from international study team, ensure IMP management, ensure the preparation for interim data analysis), communication with international study team, TMF/eTMF filing ready for inspection, organisation of investigator meeting).
Site management : Conducting periodic check-up call to ensure site participation go smoothly : state of progress, management of safety and resolution of protocol deviation, issues, assistance with informatics platform & tools, ISF filing ready to audit or inspection.
Perform e-CRF review (queries generation and resolution) to be ready for interim analysis.
Feasibility / selection study : Design and apply strategy to obtain the best site investigator recruitment (4 studies – 200 sites – 800 subjects). Submissions to the French regulatory authorities.
Therapeutic Experience:
Cardiology area :
>International, multicenter, randomized, double-blind, prospective study (phase III)
Vaccine field : open-label, multicenter, uncontrolled study (phase IV)
Diabetology area :
>International, multicenter, randomized, open-label, prospective studies (phase IV)
>International, multicenter, randomized, open-label , prospective trial (phase III)
-
CERI MEDICAL, a society of Business & Decision LifeSciences
- Study coordinator & Clinical Research Associate
2013 - 2014
Management of field based CRAs to conduct an international, multicenter, prospective observational study:
>Tasks required before the start study : regulatory submission, CRA freelance recruitment, establishment of procedures especially for the study, ensure the training (protocol, safety, GCP, eCRF of CRAs, Investigator site recruitment).
>Tasks ensured during the study: about protocol, amendments, procedures and specific documentation and eCRF of the Laboratory; organization and management of conference call.
Identified potential new investigators with Site Questionnaires to gauge interest and feasibility of study at different sites. Administrative management to elaborate investigator’s contract and center’s additional cost.
Management, organization and standardization of study data collection, to prepare international analysis by the Sponsor. Preparation of investigator site to be evaluated by audit or inspection.
Conducting of Site Initiation Visit, Source Data verification Visit and Close-Out Visit in accordance with the monitoring plan, sponsor process and GCP principles.
Therapeutic experience:
>Cardiology area :
International, multicenter, prospective observational studies (phase IV)
Local, transversal, multicenter observational (phase IV)
-
Université de Limoges
- Rédacteur de mémoire universitaire
Limoges
2012 - 2012
Rédaction de mémoires pour l'obtention du Diplôme Universitaire de Restauration Collective.
-
Institut de Génomique Fonstionnelle, UMR 5203 CNRS- U661 INSERM- Univ. Montpellier I & II
- Stagiaire Recherche Master 2
2012 - 2012
Caractérisation d’un réseau de signalisation protéique associée au récepteur 5HT2A de la sérotonine
-
Institut de Génomique Fonctionnelle, UMR 5203 CNRS- U661 INSERM- Univ. Montpellier I & II
- Stagiaire recherche
2011 - 2011
Stage volontaire portant sur l'étude de l’interaction du récepteur 5HT2A et ses partenaires protéiques impliqués dans la nociception
-
Institut de Neuroscience de Montpellier (INM, INSERM 1041)
- Stagiaire Recherche Master 1
2011 - 2011
Etude de la régulation transcriptionnelle de la Calmoduline suite à une lésion du nerf périphérique dans le ganglion rachidien de souris.
-
Laboratoire de Biologie des Ligneux et des Grandes Cultures (LBLGC,Orléans)
- Stagiaire recherche
2010 - 2010
Stage volontaire:
Elaboration d’outils en vue de caractériser l’activité de deux nouvelles aquaporines du peuplier chez S.cerevisiae.
