PIERRELAYE
RETROUVEZ GRATUITEMENTLe résultat des européennes à Pierrelaye ainsi que le résultat des européennes dans le Val-d'Oise.
January 2014-August 2016
PRA HS
Clichy Levallois
Clincial Research Associate
Therapeutic Area Experience
Oncology
Pulmunology
Myopathy
Epilepsy
Clinical Research Projects
Phase Ib – International study, Myopathy : 4 sites, 5 patients
Phase II – International study, Ovarian cancer : 4 sites, 27 patients
Phase III – International study, Ovarian cancer : 6 sites, 33 patients
Phase III – International study, Epilepsy: 7 sites, 7 patients
Phase IV – International study, Pulmonary hypertension: 7 sites, 6 patients
Responsibility
Selection, Initiation, Monitoring, Close-out visits
Participation in investigators meetings (national)
Interaction with International team (email, conference...)
eCRF training : Investigators and study nurses (Inform, Datalabs, Medidata Rave)
Biology Central Lab Training (training of study nurses) and interaction with the Central Lab (follow-up lab alert, queries, lab kit…)
Interaction with Scanner Central Lab (follow-up of results)
Interaction with the Data Management (queries, respect of the delay of database lock and intermediate analysis)
Management of clinical trial treatment (sending, accountability, storage) and site material
Training to the local and international procedures
CRA Training (co-monitoring visits)
Management and reporting of SAEs
January 2011-December2013
CHILTERN INTERNATIONAL, Neuilly sur Seine
Clincial Research Associate
Start up: Initial submission and amendment: Ophthalmology, dermatology
Phase II – international study, Oncology : 4 sites, 30 patient
Phase III – international study, Pneumology: 3 sites, 21 patients
Phase IV – international study, Psychiatric: 50 sites, 400 patients
Responsibilities :
-Monitoring Visits
-Remote Monitoring Visit
-Interaction with the data management
-Feasibility, Qualification Visits (on site and by phone),
-Initiation Visits,
- Investigator Meeting : Organization, participation and animation (national),
-EC Submissions (initial submission, substantial amendment and notification), French Regulatory body submission ( CNIL, CCTIRS, CNOM)
-eCRF training: Investigator (eCRF ClinDataManagement)
-Motivational visits, Site close out visit,
- Site Finance follow-up : Administrative and financial Follow up (Investigator invoices, incremental hospital)
From December 2009 to September2010: CIS BIO INTERNATIONAL – IBA GROUP, Saclay
Junior Product manager (MBA internship, 8 month)
Missions : Web platform development, involved in product launch, development of brochures, following of the final proof, Web 2.0 (social network), development of customer survey (Net Promoter Score), management and monitoring of event, monitoring of communication project, management trainee.
2009: INSERM, Paul Brousse Hospital, Villejuif
Master Internship (8month), Immunology
Missions : Cellular culture, purification and cell labelling
2008: GORLAEUS LAB (Leiden, the Netherland)
Leiden University, ERASMUS.
Missions: Bacterial culture, Protein purification.
Mes compétences :
Biologie
Chef de produit
Chef de projet
Communication
Immunologie
Marketing
Recherche clinique
