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Junior Clinical Research Associate

04/12/2018
- Brussels

Job content
  • You manage clinical trials from start to finish: you carry out pre-study visits, you initiate the trial, you are responsible for routine monitoring and closing visits about the quality standards and timelines
  • You obtain and update essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in a Trial Master File (eTMF) and Investigator Study File (ISF)
  • You actively participate in Local Study Team meetings
  • You train, support and advise investigators and site staff about study-related matters
  • You contribute to Investigators meetings
  • You initiate, monitor and close study sites in compliance with procedural documents. You share information on patient recruitment and study site progress with Local Study Teams
  • You are in charge of performance at the site. You proactively identify study-related issues and find the appropriate solutions
  • You update the CTMS system and other systems with data from centers, respecting deadlines
  • You carry out source data verification according to the SDV plan
  • You ensure data query resolution on site
  • You are responsible for accurate and timely reporting of Serious Adverse Events on site
  • You prepare and participate in activities related to audits and regulatory inspections
  • You provide the required monitoring visit reports, meeting the requested deadline
Profile
  • A first working experience within clinical research such as Clinical Trial Assistant or as a CRA is required
  • Master degree in Life Sciences
  • You are fluent in French and/or Dutch and English (written and spoken skills)
  • Advanced knowledge of MS Office Excel
  • You have strong communication skills and are able to build relations with the on-site staff and the internal staff (PM, CRAs, CTAs, medical advisor etc.)
  • You are flexible and easily adapt to new ways of working or new projects
  • You are capable of working independently
  • You can set and manage priorities
  • You are well-organised and able to work efficiently and effectively in a dynamic environment
Contact

Please contact us for more information on +32 16 309 509 or hello@arcq.be