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ICBE Monitor / Secretary (Freelance)
Posted Sep 14, 2021
Project ID: PHILJP00023895
Eindhoven , Noord Brabant
(Oct 1, 2021 - Sep 30, 2022)
51 - 70 €/hr
Adding an ICBE monitor / secretary resource to address high workload of current ICBE monitor/secretary team.
JOB DESCRIPTION - ICBE MONITOR / SECRETARY (CG60)
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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