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Summary

*looking for missions full time or part time* contact me to know my hourly fee. French, English, spanish working in france, uk, belgium, switzerland, spain. degree in Biology and Clinical research. passionated, bright, curious, independent and ordered * anglais: conversational * espagnol: conversational * autonomous, organized, mobile * gcp,glp * oncology (pulmonary and Hematology), Anesthesia, Medical Device, sepsis, antibiotics, ventilation, Orthopedic, Vascular surgery, * coordination, organization and realization of all circuit of Clinical trials phases ii to iv * site monitoring spécialités : Therapeutic Areas : oncology (pneumology, Hematology), intensive care (antibiotics, ventilation, sepsis...), Anesthesia, Orthopedic, Medical Device, Vascular surgery mobile

Experiences

Current Experience

  • Home based CRA


    Since November 2009
    • monitor the conduct of Clinical trials, especially enrollment and quality of data. • verify subject safety and site adherence to FDA regulations and ich/gcp guidelines. • ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary. • review crf, Informed Consent documents and query language/narratives. • acquire specific clinical and therapeutic knowledge related to studies monitored, particularly Hematology with myeloma and lymphoma • conduct Qualification, initiation, Interim and closeout monitoring visits. • ensure complete and thorough study drug reconciliation. • manage trip reports, letters, query resolutions and expenses. • manage site master file contents and work with sites to ensure Communication requirements between site and irb are adhered to. provide support and timely follow-up for all audit and Quality Assurance activities. • Monitor the conduct of clinical trials, especially enrollment and quality of data. • Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines. • Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary. • Review CRF, Informed Consent Documents and query language/narratives. • Acquire specific clinical and therapeutic knowledge related to studies monitored, particularly hematology with myeloma and lymphoma • Conduct Qualification, Initiation, Interim and Closeout monitoring visits. • Ensure complete and thorough study drug reconciliation. • Manage trip reports, letters, query resolutions and expenses. • Manage site master file contents and work with sites to ensure communication requirements between site and IRB are adhered to. Provide support and timely follow-up for all audit and quality assurance activities.

Past Experience

  • Clinical Research Associate (CRA)

    October 2007 --- June 2012
    participating in feasibility surveys, Investigator recruitment, Investigator network extension, participating Investigator meeting, administrative and Logistics Management of Clinical studies (patients pre-screening and randomisation, follow-up and monitoring), eCRF completion (rave medidata, inform, eclinical, rdc,oracle...), ecg centralized, ivrs, all science)" rel="nofollow">Protocol’s requirements, management of the CRA team, participation in monitoring and audits visits

Knowledge

LinkedIn Assessment :
Clinical trialsClinical researchClinical monitoringRemote MonitoringHome Based BusinessBiologyMedical DevicesHematologypneumologyIntensive CareAnesthesiaOrthopedicPharmaceutical IndustryEssais cliniquesRecherche clinique

Education

  • Master's degree in Medicines: innovation and conception (clinical research and pharmaco from Université Rennes 1 in 2007
  • Master's degree in Cellular Biology and Physiopathology from Université Bordeaux II in 2006
  • in from DEUG et licence Sciences de la Vie Université Victor Segalen Bordeaux 2 in 0000

Area / Region

Aix-en-Provence, France

Others

Driving License
  • No

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