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CRA I

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About the role

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Identify, select, initiate, and close-out appropriate investigational sites for clinical studies.  Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP.  Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.  Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
 
Overview of the Role
  • Travel (approximately 60%) domestic and/or international
  • 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.
    • Ensure correct archiving of files on completion of a study.
    • Maintain patient and sponsor confidentiality.
    • Assume additional responsibilities as directed by Project Manager (PM).
    • Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.
    • Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
    • Co-ordinate and/or participate in feasibility studies for new proposals, as require
  • Investigational Products (IPs) stored and managed by the site:
    • Ensure storage conditions and acceptable supplies are provided
    • Ensure IPs is 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.
  • Be cost effective.
  • Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
  • Participate in data listing reviews, as applicable.
  • Assist with marketing the company if and when appropriate.
  • Other duties as assigned.
Role Requirements / Skills / Experience Required
  • Bachelor’s degree or equivalent in medicine, science or related discipline.
  • Experience should include monitoring skills and understanding of field monitoring requirements 
  • Minimum of 18 months experience as a CRA I 
  • Ability to review and evaluate clinical data.
  • Computer literacy desirable
  • Good oral and written communication skills.
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