Reine Huguette MATÉNÉ

En résumé

Entreprises

• Scimega Research Inc. - Clinical Research Associate

  2016 - maintenant
  • Monitor study centers in respect to ICH GCP and Scimega or Sponsor SOPs
  • Verify source documents and case Report Forms, assesse data completeness, accuracy and integrity
  • Serve as liaison between the sponsor and the investigator
  • Reconcile study medication stocks, verify storage conditions and inventory/shipment documentation
  • Review the lnvestigator file as required to maintain up-to-date and accurate investigator study files
  • Review adverse events for accurate recording and reporting
  • Review and correct site specific/local ICFs so that they are accurate to the sponsor ICF
  • Escalate to the project manager, all issues related to the study trial process
  • Followed-up with study vendors in order to resolve imaging and central laboratory queries and comply with protocol requirements
  • Prepare and submit written reports of investigation site findings following site study visits
  • Act as a resource for investigational site queries resolution
  • Train site personnel on all aspects of study requirements
  • Participate in project team meetings and conference calls
  

• CRA School of Montreal, Montreal, Quebec - Clinical Research Associate - In-house consultant

  2015 - 2016 • Generated simulated patient records for CRA training purposes
  • Mentored CRA students in training with simulated site visits and simulated study data review
  • Supervised CRA students in their visit preparation, conduct and reporting
  • Trained CRA students on Canadian regulatory documents and study documentation requirements
  • Edited templates of informed consent forms according to local regulations and GCP required essential elements.
  • Verified CRFs completion
  

• Federation francophone de cancerologie digestive - Assitante de Recherche Clinique

  2013 - 2014 • Conducted site initiation, monitoring and close out visits (includes 170 monitoring visits in oncology)
  • Monitored study centers in respect to ICH GCP, local regulations and sponsor SOPs
  • Verified source documents and Case Report Forms, assessed data completeness, accuracy and integrity
  • Served as liaison between the sponsor and the investigator.
  • Reconciled study medication stocks, verified storage conditions and inventory/shipment documentation
  • Reviewed the Investigator file as required to maintain up-to-date and accurate investigator study files
  • Reviewed adverse events for accurate recording and reporting
  • Prepared and submitted visits written reports of investigation site findings following site study visits
  • Acted as a resource for investigational site queries resolution
  • Prepared site personnel and site documentation for Audit
  

• Robert Debré - Technicienne d'Etudes Cliniques

  2010 - 2011 gestions des projets en relations avec les investigateurs et le promoteur

• Robert Débré - Ingénieur de Recherche Clinique

  2010 - 2012 • Coordinated 4 clinical trials in obstetrics and gynecology, pediatric and pediatric hematology
  • Explained clinical studies to patients, conducted and documented the informed consent process, and reviewed patients’ medical history and eligility criteria
  • Trained patients with the use of sampling kits as required by study protocols
  • Assess the feasibility of the studies according to specific protocol requirements by actively engaging in clinic logistics planning, reviewing and/or finalization of clinic source documents, ordering study supplies, and training team members as needed
  • Implement patient recruitment strategies with clinical sites
  • Scheduled patients' study procedures in compliance with study protocol schedule of events
  • Shipped patient samples as required by study protocols.
  • Randomized patients using lVRS systems
  • Prepared and reconciled source documents and patients charts in preparation for monitoring visits
  • Performed data entry in the CRF/eCRF and query resolution
  • Prepared site documentation for monitoring visits, and assisted Clinical Research Associates during monitoring visits
  • Reported local SAEs in order to comply with REB reporting requirements and sponsor
  reporting requirements
  • Attended and organized various coordinator meetings
  • Designed internal trackers to follow the progress of the study
  • Prepared for and participated in sponsor audits
  
  

Formations

Pas de formation renseignée

Réseau

• Adonis HAZOUMÉ

• Vanessa HINDER

• Viviane KAMBEU BOUOM