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Clinical In-house Monitoring

Job Summary

Responsible for performing clinical monitoring tasks and duties in accordance with regulations. Manages, coordinates, and supports clinical monitoring activities.

Primary Responsibilities

  • Monitor clinical trials from pharmaceutical companies and biotech companies, in-house.
  • Manage, coordinate, and support clinical monitoring activities, including investigator and site selection.
  • Collect regulatory documentation and ensure accuracy.
  • Collect drug and supply management.
  • Perform data collection.
  • Conduct visits and preside over prequalification, qualification, initiation, monitoring, and termination.
  • Receive inbound and outbound calls.
  • Review recruitment plan and enrollment updates.
  • Resolve issues from previous visits.
  • Address protocol questions.
  • Assess drug supply status.
  • Request outstanding documents and ensure they are filled out.
  • Perform data entry.
  • Review site payment status.
  • Create and distribute study document.
  • Complete in-house site specific files.
  • Monitor relevant tracking system.
  • Train team members.
  • Perform regular reviews of data according to data review/monitoring guidelines.
  • Develop and write trial protocols.
  • Monitor the trial throughout its duration, which involves visiting the study centers on a regular basis.
  • Set up study centers and ensure all documentation is present.
  • Close down centers upon completion of trial.