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Clinical Trial Associate

offline
  • 50€/Stunde
  • 8953 Dietikon
  • Weltweit
  • pt  |  en  |  de
  • 26.10.2018

Kurzvorstellung

Professional with a lot of experience in clinical research and all the processes in the field.

Ich biete

  • Projekt-Qualitätssicherung

Projekt‐ & Berufserfahrung

Clinical Research Associate
Bayer CropScience AG, São Paulo
6/2016 – 10/2017 (1 Jahr, 5 Monate)
Life Sciences
Tätigkeitszeitraum

6/2016 – 10/2017

Tätigkeitsbeschreibung

• Responsible for monitoring an Oncology Study with 74 patients included;
• Responsible for Observational Studies;
• Support the Clinical Project Manager;
• Responsible for identification of potential sites and for start-up activities;
• Development of Clinical monitoring plan;
• Quality Assurance;
• Regulatory Submission;
• On site and in house monitoring activities;
• Site Qualification activities;
• Monitoring activities;
• Vendors coordination
• Close-out activities;
• eTMF management;
• Regulatory documents collection;

Eingesetzte Qualifikationen

Pharmazie

Clinical Research Associate
Genexion Clinical Research, São Paulo
7/2011 – 12/2013 (2 Jahre, 6 Monate)
Life Sciences
Tätigkeitszeitraum

7/2011 – 12/2013

Tätigkeitsbeschreibung

• Responsible for managing 20 sites in Brazil, 03 sites in USA and 03 sites in Portugal
• Responsible for identification of potential sites and for start-up activities
• Perform pre-study visits, contract and budget negotiation as well as preparation of regulatory package for ECs and follow up in regards to timelines completion
• Responsible for site initiation, monitoring and close out visits, preparation for database lock and audits
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
• Coordination of ordering/ dispatch and tracking of trial materials
• Update the Clinical Trial Management Systems
• Review of translated documents
• Report and follow up of SAEs

Eingesetzte Qualifikationen

Projektorganisation

Clinical Trial Assistant
ICON Clinical Research, São Paulo
7/2009 – 12/2010 (1 Jahr, 6 Monate)
Life Sciences
Tätigkeitszeitraum

7/2009 – 12/2010

Tätigkeitsbeschreibung

• Support the Clinical Research teams with ongoing conduct of studies
• Preparation, handling and tracking of Ethics/ Regulatory submissions
• Coordination of Investigator payments
• Coordination of ordering/ dispatch and tracking of trial materials e.g CRFs, Diary Cards, Lab Supplies, Drug Supplies as appropriate
• Update the Clinical Trial Management Systems
• Participate in Investigator’s and CRA Meetings
• Conduct study feasibilities

Eingesetzte Qualifikationen

Projektassistenz

Clinical Research Trainee
Stiefel Laboratories (a GSK Company), São Paulo
7/2006 – 12/2007 (1 Jahr, 6 Monate)
Life Sciences
Tätigkeitszeitraum

7/2006 – 12/2007

Tätigkeitsbeschreibung

• To initiate, accompany and close local clinical studies on trials sites.
• To monitor Clinical Studies according to international clinical research standards and local legislation
• To manage investigator’s payments of clinical studies and CROs.
• Management of clinical and pre-clinical studies
• Elaboration of dossiers of regulatory process for Brazilian MoH.
• Review of contracts for investigators
• Close communication with study site sfaff, CROs and internal colleagues locally and globally
• Develop and maintain tracking system for clinical projects
• Participation in global and local project teams of development of new products
• Assist with the management of study supplies and organize shipments
• Pharmacovigilance activities: report, follow-up of SAEs and report to local healthy authorities

Eingesetzte Qualifikationen

Projektassistenz

Ausbildung

MedizinInformatik
(Bachelor)
Jahr: 2020
Ort: Bern - Switzerland
Pharmacy and Biochemistry
(Bachelor)
Jahr: 2011
Ort: São Paulo - Brazil

Qualifikationen

Clinical Research Professional with great experience in all trial stages.

Persönliche Daten

Sprache
  • Portugiesisch (Muttersprache)
  • Englisch (Fließend)
  • Deutsch (Gut)
  • Spanisch (Gut)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Schweiz
Profilaufrufe
654
Alter
36
Berufserfahrung
15 Jahre und 4 Monate (seit 08/2006)

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