Study Startup Specialist I
About this role
About the Role Take your career to the next level by leading challenging study activation processes at the country level. You will support clinical research teams and ensure PSI projects start smoothly and on time. What You'll Do
- 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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