Senior CRA
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.
Application process
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