Study Startup Specialist II

PSI CRO

full-time Business Operations Specialists
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Location
Mississauga, Ontario, Canada
Posted
July 05, 2026

Job Description

Job Description

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

You will: 

  • Collaborate with the project team for site activation processes
  • Facilitate site agreement, contract negotiations and budget negotiations
  • Collect site documents for IRB/IEC submission and/or IP-RED process
  • Coordinate translation and review of study-specific documents
  • Identify and escalate project-specific issues as needed
  • Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
  • Prepare IP-REDs packages
  • Support initial distribution of Investigational Product(s) and clinical study supplies to sites
  • Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
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