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IHCRA - Office based in Johanesburg

JR068025

About the role

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In-House CRA
Office Based in Johanesburg
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

The Role
  • Become familiar with ICON's SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
  • Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
  • Serve as the primary in-house contact for sites and investigators participating in studies
  • Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
  • To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
  • Take responsibility for project tasks and sees these tasks through to successful completion, with support.
  • Maintain a professional interpersonal relationship with study team, sites, and Sponsors
  • Participate in QA Audits as needed.
  • Regularly attend and gives to project specific and departmental meetings
  • Ability and willingness to travel as needed (drive and fly)
  • Maintain Sponsor and patient confidentiality
  • Other duties as assigned

What you need
  • Minimum Bachelor's degree in a life science
  • At least 12 months of a CTA/Clinical Trial Assistant or similar role experience within the clinical/pharmaceutical industry
  • Understanding of ICH GCP Compliance
  • Excellent communication and organizational skills
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