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About the role ICON and you Application Process Day in the life Who we are

CRA II

051213_2

About the role

This vacancy has now expired. Please click here to view live vacancies.
Job Description:
  • 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 is 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.(lnternational and domestic : fly and drive) 
  • Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.
  • Familiarity with ICON system, maintain timelines, and ensure accuracy and completeness of data entered into ICON systems
  • Recruitment of investigators 
  • Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following: 
    • Identify investigators. 
    • Help when requested, in preparation of regulatory submissions
    • Design of patient information sheets and consent forms
    • Ensure timely submission of protocol/consent documents for ethics/IRB approval
    • 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 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. 
    • Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study
    • Maintain patient and sponsor confidentiality
    • Assume additional responsibilities as directed by the Project Manager 
    • Investigational Products (IPs) stored and managed by the site:
      • Ensure storage conditions and acceptable supplies are provided
      • Ensure IPs are supplied only to eligible patients
      • Ensure IP receipt, use and return are controlled and documented
      • Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
      • Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate
      • Participate in data listing reviews, as applicable
      • Responsible for cost effectiveness
      • Participate in training and mentoring new staff up to Clinical Research Associate level as appopriate
      • Assist with marketing the company if and when appropriate . Other duties as assined
Experience, Skills, and Education:
  • Bachelor's degree, or local equivalent, in medicine, science, or related discipline
  • Experience independently field monitoring as a Clinical Research Associate - at least 12 months. 
  • Ability to review and evaluate clinical data
  • Must be able to travel 65%-75% per month
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