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Clinical Research Associate

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Laura Schollen
Recruiter



Laura Schollen
Recruiter


Jobomschrijving

  • As a CRA, you will manage clinical trials in different phases and different therapeutic areas:
  • You manage projects from start to finish: you carry out pre-study visits, you initiate the project, 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 contribute to the selection of potential investigators
  • You train, support and advise investigators and site staff about study-related matters
  • You contribute to National 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 IMPACT and other systems with data from centers, respecting deadlines
  • You manage study and drug supplies and track the drug accountability at the study sites
  • 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 activities related to audits and regulatory inspections together with the local Study Team Lead and the CA&A
  • You provide the required monitoring visit reports, meeting the requested deadline
  • You work with Data Management to ensure the quality of the study data
  • You ensure compliance with the company’s Code of Conduct and policies and procedures concerning people, finance, technology, security and SHE (Safety, Health and Environment)

Profiel

  • You have at least 1 to 3 years of experience with monitoring
  • You obtained an Master's degree in one of the Life Sciences
  • You are fluent in Dutch, French and English (written and spoken skills)
  • You dispose of advanced knowledge of MS Office and particularly Excel
  • You have strong communication skills and are able to build relations with the on-site staff and the internal staff (LDL, 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

Aanbod

Temporary position

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