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Thursday, 6 October 2016

Job Description


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  1. Facilitate and coordinate with investigator and site for EC submission and approval.
  2. Conduct site feasibility and qualification visits.
  3. Get trained on trial and documents.
  4. Prepare for kickoff
  5. meetings to train vendor representatives involved if outsourced
  6. activity for monitoring.
  7. Coordinate with investigator and sites for IM and assist PM in planning for IM
  8. Conduct SIVs, write SIV reports, and dispatch to sites
  9. Resolve queries and problems at sites and with vendors.
  10. Monitor sites, write monitoring visit reports and send timely monitoring followup
  11. letters to sites.
  12. Obtain updated weekly trackers from sites
  13. Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
  14. Coordinate with data management team and investigator/site team for timely DCF resolution.
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