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Aurélie VINCENT

PIERRELAYE

En résumé

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

Entreprises

  • PRA HS - Attachée de recherche clinique

    2014 - 2016 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

  • Chiltern International - Attaché de recherche clinqiue

    Slough 2011 - 2013 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)

  • École de commerce ESG - Étudiant

    2009 - 2010 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.

Formations

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