Study Start up Specialist, IQVIA Biotech

IQVIA · Durham, NC

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Clinical OperationsFull-time$48k–$123kCompany career page

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Role summary

IQVIA seeks a Study Start Up Specialist to manage site activation activities for clinical trials at the country level. The role involves coordinating between investigative sites and internal teams, preparing regulatory documentation, and ensuring adherence to timelines and quality standards.

What they're looking for

1 year of clinical research experience or equivalent education and training
Site activation experience with Informed Consent Forms in US and Canada
Experience reviewing ICF elements using checklists for site-specific and central IRB forms
Demonstrated ability to track regulatory and contractual document approval and execution
Proficiency with internal systems, databases, and project tracking tools

What you'll be doing

Serve as single point of contact for assigned studies between investigative sites, project management, and internal teams
Prepare and review site regulatory documents for completeness and accuracy
Manage database entries and tracking tools with project-specific information
Monitor site performance metrics and report findings to management
Track progress and approval of regulatory, ethics, ICF, and investigator pack documents

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