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ICBE Monitor / Secretary (Freelance)

Posted Sep 14, 2021
Project ID: PHILJP00023895
Eindhoven , Noord Brabant
1 year
(Oct 1, 2021 - Sep 30, 2022)
40 hrs/week
Payrate range
51 - 70 €/hr

Adding an ICBE monitor / secretary resource to address high workload of current ICBE monitor/secretary team.


Key Areas of Responsibility (KARs)

  • Monitor clinical studies involving medical/non-medical devices at clinical sites according to Good Clinical Practices for Medical Devices (ISO14155). 
  • Support, update and maintain the Clinical Trial Management System application for clinical study execution and reporting. 
  • Facilitate reviews by internal privacy, legal, regulatory affairs, risk management and ethics domain experts for al study protocols as Secretary of the CTO Internal Review Committee [also known as the Internal Committee for Biomedical Experiments (ICBE)]. This includes a Secretary pre-review step.
  • Participate in the development and maintenance of process documents, templates, guidelines, training material, FAQs and IT tools (e.g. ORION-ICBE and CTMS) linked to the CTO research review structure.
  • Schedule and manage meetings as Secretary of the CTO Internal Review Committee. 

    Minimum Required Competencies
  • Bachelors degree in life sciences or related medical/scientific field.
  • Clinical Research Associate (RCA) certification.
  • 3+ years experience in monitoring clinical studies including qualification, initiation, interim, and close-out monitoring activities. 
  • Demonstrated knowledge of Good Clinical Practice (GCP) and FDA(USA) regulatory requirements for the conduct of research involving human subjects. 
  • Experience in conducting Clinical Trials utilizing Electronic Data Capture platform.
  • Must be willing to travel in Europe for monitoring activities.
  • Experience in working with the following software tools: MS Word, MS Excel, MS PowerPoint.
  • Fluent in English (verbal and written, especially scientific writing).
  • Demonstrated ability to work effectively in cross-functional and geographically diverse teams, including the ability to plan and facilitate face-to-face and digital meetings.

    Additional Preferred Competencies
  • Experience in the medical device industry and testing products in related fields 
  • Experience in lean and agile ways of working.
  • Ability to work in high pressure contexts requiring multi-tasking.

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