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Centre de loisir Aimé Cézaire, Le Kremlin-Bicêtre
- Animatrice
maintenant
Grand jeux, activités manuelles. Enfants de 6-12 ans
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PEP, Lamoura
- Animatrice 9-12 ans
maintenant
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B-Com
- Clinical Project Manager
2019 - maintenant
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Iris Pharma
- Coordinator Clinical Research Associate
Dubai
2016 - 2019
Operational management and coordination of international clinical trials in ophtalmology:
-> Phase II - Dry-Eye Disease (~260 patients, ~50 sites, 10 countries)
-> Phase III - Dry-Eye Disease (~ 450 patients, ~150 sites, ~20-25 countries)
-> Phase III - Glaucoma (~400 patients, ~100 sites, ~15-20 countries)
Set up of an international Medical Device Clinical Investigation in Acute conjunctivitis (Spain, Georgia, Morocco) - ISO 14155
- Coordination of Monitoring activities of internal and external CRA (~30) : Report review (~500), issues escalation, Deviations FUP and classification, CRA training, CRA regular meeting conduct
- Participation to sites selection and evaluation
- Participation to Investigator Meeting
- Follow-up of study recruitment
- Regular reporting of study progress to sponsor (weekly TC + monthly reports)
- Creation, review and update of study documents: Protocol, Patients documents (ICF, card, diary), Laboratory manual, IMP management guideline, Newsletters, Study follow-up trackers, FAQ, Project Plan, Monitoring Plan, Risk Log …
- eCRF: creation, validation, testing, users activation, data reconciliation (data cross-check with IWRS, data analysis, queries status Fup)
- Regular communication/interactions with Regulatory Affairs Unit and Subcontractors (Data Management, Pharmacovigilance, Logistic supplier, Monitoring CRO, Central laboratory...)
- TMF update + Quality Control
- Site Monitoring Visits Conduct (France, Belgium, UK, Denmark, Sweden): Source Data Review & Verification, issues/queries follow-up, IMP accountability reconciliation, IF update
- Site Evaluation Visits / Site Initiation Visits / Site Close Out Visits
- Participation to the CAPA (Corrective And Preventive Action) system: Writing and follow-up of Non conformities
- Audit preparation
- Standard Operating Procedure and associated documents update
Courses:
- 11-15 Jun 2018: Clinical Project Manager - Formatis, Paris
- Feb 2017: "ICH-GCP (E6 R2) training" - Whitehall
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TxCell
- Attachée de Recherche Clinique
Valbonne
2015 - 2016
Operational coordination of an international phase IIb trial in Crohn's Disease (personalized cellular immunotherapy), and support to Clinical Project Manager
- Coordination of the subcontractors activities
- Follow-up and reporting of study progress (tools creation and management)
- Creation and update of study documents: Protocol, Informed Consent Form, patients documents (card, memo, diary), monitoring plan, eCRF completion guidelines, IWRS user manual…
- Co-monitoring, Monitoring, monitoring report review, issues escalation/resolution
- Slot booking management
- Newsletter and motivation email elaboration
- CRA (CRO) and manufacturing team training (on Crohn's disease and study specificities)
- Organisation and participation to an Investigator Meeting / CRA meeting. Training on study updates.
- Clinical quality system management, SOP creation and review
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CHU de Nice
- Attachée de Recherche Clinique
Nice
2011 - 2014
Gestion et coordination d'études cliniques de phase II / III / IV à promotion industrielle et institutionnelle (environ 20 études) en gastro-entérologie dans le respect des Bonnes Pratiques Cliniques. (Maladies Inflammatoires Chronique de l'Intestin, nutrition, cancérologie digestive)
- Soutien à l'investigateur dans le recrutement des patients (vérification du respect des critères d'inclusion)
- Création d'outils facilitant le suivi du nombre d’inclusion, le respect des délais, le suivi des évènements indésirables et traitements concomitants
- Planification et organisation des visites des patients: Visit calculator, IWRS, réalisation de tests neurologiques...
- Recueil et saisie des données cliniques dans des eCRF (MedidataRave, Perceptive Datalabs, RDC, Inform...)
- Gestion des échantillons biologiques (Formation IATA)
- Gestion des demandes de clarification (queries)
- Rédaction de procédures qualités internes à l'URC
- Rédaction des modes opératoires spécifiques à la réalisation de chaque essai clinique
- Participation à l'élaboration des grilles de surcoûts
- Préparation d'Audit
- Formation et encadrement de stagiaires
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CHU Nice - Hématologie / Néphrologie
- Stagiaire Attachée de Recherche Clinique
2011 - 2011
Gestion d'études cliniques interventionnelles oncohématologie et observationnelles en néphrologie; Data Management
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Centre de Loisir Giono - Cagnes sur Mer
- Animatrice
2011 - 2011
1 mois d'animation (activité manuelles, artistiques, sportives) avec des 7-10 ans
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Center for Neurogenomics and Cognitive Research, VU University, Amsterdam
- Stagiaire en recherche (comportement animale)
2010 - 2010
"Impact of juvenile stress on fear extinction and re-extinction in two mouse
substrains C57BL/6J and C57BL/6NCrl: Modeling aspects of Posttraumatic Stress Disorder"
Animal behaviour (Forced Swimming test, passive avoidance, elevated plus-maze)
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Laboratoire de Neurobiologie de l'Apprentissage, de la Mémoire et de la Communication, Orsay
- Stagiaire en recherche
2009 - 2009
Recherche de la plasticité synaptique de la voie amygdalo-préfronto-striatale après apprentissage. (Western Blot, immunohistochimie, microtome, conditionnement animal)
