Experience

SAINTE CATHERINE, INSTITUT DU CANCER AVIGNON-PROVENCE

• France
• Wellness and Fitness Services
• 100 - 200 Employee

• Clinical Research Associate

  • Jul 2017 - Present

  My main tasks concern different studies in oncology (RIPH 1, 2, 3) which cover mostly 3 therapeutic areas : Breast cancer trials, gynecological cancer trials and supportive cares. I am in charge of the opening of clinical trials on my site by ensuring the management of administrative documents (SSDL, CV, ICH-GCP, trainings, certificates), the patient care according to the protocol with the different departments (the consultations, the laboratory, the imaging department, etc.) Screening, randomization and inclusion of the patients Follow up the patients according the protocol (study assessments, PK samples, radiological assessments) Data completion via eCRFs Provide all required documents for the study closure I am also in charge of ensuring the good follow up of trials as preparing all necessary documents for the monitoring visits of each sponsor : Update investigator files, respond to the queries and respond to the pending actions to facilitate the monitoring. Since 2021 : The research department developped some projects as a sponsor as part of the reference methology 004 (MR004). Since 2 years, I am in charge of some datasets : Participating of the elaboration of clinical basis, collecting clinical data according to the plan project, cleaning databasis in order to send them for statistic analysis. Finally, a part of my job is to apply the SOPs according to the ISO 9001 quality standard. Show less



University of Montpellier

• France
• Higher Education
• 700 & Above Employee

• Étudiante Master 2 - Gestion des essais Thérapeutiques - Thérapies Innovantes

  • Sep 2011 - Aug 2017



CHU Saint-Etienne

• Région de Saint-Étienne, France

• Clinical research associate internship

  • Mar 2017 - Jul 2017

  Monitoring (on site and outsite) Regulatory affairs : CPP submissions, ANSM submissions/statements (to inform, to obtain an ID RCB) SAE statements SIGREC statements Monitoring (on site and outsite) Regulatory affairs : CPP submissions, ANSM submissions/statements (to inform, to obtain an ID RCB) SAE statements SIGREC statements



CHU de Montpellier

• France
• Hospitals and Health Care
• 700 & Above Employee

• Clinical research associate internship

  • Oct 2016 - Feb 2017

  Management and communication of research calls for projects and calls for tenders. Work with investigators and researchers to develop their projects and find financing, for France and Europe (PHRC, Horizon 2020) Participation to the elaboration of research projects and clinical studies since the obtaining of the budget to the kick off of the project (including regulatory affairs, the search for partnerships). Management and communication of research calls for projects and calls for tenders. Work with investigators and researchers to develop their projects and find financing, for France and Europe (PHRC, Horizon 2020) Participation to the elaboration of research projects and clinical studies since the obtaining of the budget to the kick off of the project (including regulatory affairs, the search for partnerships).



CHU de Montpellier

• France
• Hospitals and Health Care
• 700 & Above Employee

• Master 1 - internship

  • Mar 2016 - Aug 2016

  Clinical reasearch associate internship - Pediatric hematology and oncology department : - Initiation to the different pediatric pathologies - Initiation to the clinical trial specificities in pediatry - Management of pediatric studies (inclusion, completion, SAE, follow up, closure) Clinical reasearch associate internship - Pediatric hematology and oncology department : - Initiation to the different pediatric pathologies - Initiation to the clinical trial specificities in pediatry - Management of pediatric studies (inclusion, completion, SAE, follow up, closure)



CHU de Montpellier

• France
• Hospitals and Health Care
• 700 & Above Employee

• Clinical research associate internship

  • Jun 2015 - Jun 2015

  Initiation to the clinical research associate job in the geriatry and neurology department : investigative tasks such as screening, inclusion, randomisation, completion of eCRF/CRF. Initiation to the clinical research associate job in the geriatry and neurology department : investigative tasks such as screening, inclusion, randomisation, completion of eCRF/CRF.