October 2016 --- May 2017
I was working and traveling around these two countries.
Clinical Research Associate (CRA)
September 2015 --- October 2016
Active participation at three studies (41 on-site visits) : _Phase IV in diabetology (national study) : CRA 2 study selection visits 10 study initiation visits (training of investigational team (protocol, eCRF), green light, report) 15 monitoring visits 2 close-out visits Investigational product management Remote monitoring _Phase III in diabetology and pediatrics (international study) : project manager triptych achievement assistance to the achievement of informed consent _Phase III in cardiology (international study) : CRA 12 monitoring visits reconciliation of investigationals products trackers and loading of eTMF Tutor : Hocine TACHOUAFT Cardio-metabolism pole ; French Speaking Clinical Study Unit Sanofi Aventis France
Internship in Clinical Hematology.
April 2015 --- August 2015
Study coordinator mission : _patient monitoring, _eCRF achievement, _using medical records, _SAEs declaration, _management of documents for Biomedical Research Studies : _industrial and international phase III : vaccine for hematopoietic transplant patients _insitutional phase III : hematopoietic transplantation and graft versus host _prospective cohort study : clinical and laboratory data of patients with hematological malignancies _observational study : antifungal for hematopoietic transplant patients Tutor: Valérie ROUILLE. Clinical Hematology Unit. Saint-Eloi Hospital.
Internship in Pediatrics.
January 2015 --- January 2015
Discovery of the Clinical Research Associate job, in a pediatric unit. Tutor: Dr Eric JEZIORSKI. General Pediatric, Infectious Diseases and Clinical Immunology Unit. Arnaud de Villeneuve hospital.
Research Internship in Genetics and Oncogenesis.
April 2014 --- May 2014
Proteomic study of DNA repair of the BER pathway complex. Tutor: Alexender ISCHENCKO.
AdaptabilityAttention to detailCommunicativeFlexibilityInterest in knowledgeOrganization
Diabetes R&DBiological Drug DevelopmentBiologyCardiovascular diseasesCDISCCE CertificationClinical monitoringClinical operationsTeamworkStandard Operating Procedure (SOP)Phases of clinical development (phase I to IV)Good Clinical Practice (GCP)
Skills and Expertise
Work collaboratively with the other members of the clinical research team Verify dataValidate dataUnderstand protocolsTranslate protocol into packaging and labeling requirementsSerious Adverse Event (SAE) ReconciliationSelect sitesSelect investigatorsScreen patientsSchedule trial visitsResolves queries Build and manage the Trial Master File (TMF)Conduct site initiationConduct studiesEnsure good clinical practice (GCP)Ensure data integrityEstablish relationships with Key Opinion LeadersEstablish professional relationships with partnersInteract with pharmacistsInteract with nursesInteract with KOLInteract with physiciansInteract with regulatory stakeholders
Master’s degree in Clinical Research from Université de Montpellier in 2016
1st year of Master Degree in Biology, Health from Université d'Angers in 2014
Bachelor's degree in Biology, Health from Université de Bordeaux in 2013