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ARCQ

CRA

Via ARCQ

Staat 12 dagen op Jobat.be

Providing smart staffing solutions to the life sciences, chemical and food industries is what we are good at.
Our exclusive focus gives us a sharper edge, and our commitment to quality implies we recruit only the best. 
We guarantee discretion, integrity and transparency.  
Moreover, we value and nurture a culture of enthusiasm, professionalism and commitment. 

CRA

Functieomschrijving

Job content

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
Leuven

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Kenmerken

Vereisten

  • Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type)
  • Minstens 5 jaar ervaring
  • Nederlands, Frans, Engels

Aanbod

  • Onbepaalde duur
  • Voltijds

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