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Senior CRA

052418_2

About the role

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  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People Clients and Performance.
  • As a member of staff, the employee I expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Ability and willingness to travel at least 60% of the time (international and domestic: fly and drive)
  • Expert knowledge of ICON Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations.
  • Expert knowledgeable of ICON systems.
  • Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
  • Recruitment of investigators.
  • Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following: Identify investigators. Help,when requested, in preparation of regulatory submissions.
  • Design patient information sheets and consent forms.
  • Co-ordinate. documents translation, verification and back translations where required. Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements. Pre Study/placement and initiation visits.
  • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP, as appropriate Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets.
  • Complete accurate study status reports. Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs. Keep the project manager or designees regularly informed.
  • Process case record forms to the required quality standards and timelines.
  • Deal with sponsor generated queries in a timely manner.
  • Ensure the satisfactory close-out of investigator sites. Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
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