The Ugandan Jobline

• Regularly
  monitor the clinical trial site with regards to protocol compliance and
  ICH-GCP requirements.
• Provide
  back up and support for external monitors and audits as required.
• Communicate
  with the sites the findings and follow up of all pending issues.
• Initiate and maintain the sponsor trial
  master file as appropriate.
• Ensure
  completeness and consistency of the study data with the study’s
  investigators.
• Support
  and respond to requests from the trial site team members and
  investigators on trial related matters.
• Work
  collaboratively with the data manager/statistician of the study for the
  data cleaning.
• Provide
  support for coordination office duties, e.g. logistics and trainings.
• Follow-up
  pharmaceutical regulatory requirements, documentation and
  processes.   
• Provide
  assistance in ICH GCP training for the investigators as required.
• Put
  into practice the research protocol.
• Develop
  and update monitoring standard operating procedures for the study.

• The
  applicant should preferably hold a University degree in a related health
  profession or a field related to research compliance.
• Previous
  experience on clinical trial study and monitoring experience is an
  asset.
• Working
  knowledge of ICH guidelines, GCP, and the clinical trial study process.
• Demonstrated
  ability to work effectively in teams as well as independently.
• Excellent
  verbal and written communication skills.

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