Study Startup Specialist I
Core
Coordinate clinical study start-up activities in Australia, managing site contracts, regulatory documentation, and activation timelines.
Role type
Clinical research start-up specialist
Builds
Clinical trials
Domain
Healthcare / Clinical Research
Required skills
Clinical trial start-up coordination, site contract negotiation, regulatory document management, ethics committee submission support, timeline development, enrollment projection, Trial Master File (TMF) maintenance
Preferred skills
Experience with multi-stakeholder coordination, translation review
Technologies
Trial Master File (TMF)
Responsibilities
Maintain study-specific and corporate startup tracking systems, Facilitate site budgets and contract negotiations, Support site regulatory document collection, Prepare initial/amendment submission dossiers to ethics committees under supervision, Communicate with project teams and investigational sites, Develop site-specific startup timelines and enrollment projections, Maintain the Trial Master File (TMF)
