Study Startup Specialist I
Core
Coordinate clinical study start-up activities from site contracts and regulatory documentation through to site activation in Australia.
Role type
Clinical research start-up specialist
Builds
Clinical trials for pharmaceutical clients
Domain
Pharmaceutical clinical research
Required skills
Clinical development experience, site contract negotiation, regulatory document collection, ethics committee submission support, timeline development, TMF maintenance
Preferred skills
EC submission experience, pharmaceutical/healthcare degree
Technologies
MS Office (Word, Excel, PowerPoint, Outlook)
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
Seniority
Entry-level to Mid-level
