26 Sep
|
Psi Cro
|
Australia
Job Description
Are you ready to play a key role in getting clinical trials off the ground?
We are looking for a motivated clinical research qualified to join our team and support the successful start-up of clinical studies in Australia. In this role, you will work closely with project teams and investigational sites, coordinating activities from site contracts and regulatory documentation through to site activation. This is a excellent prospect for someone with clinical start-up experience who enjoys working across multiple stakeholders, taking ownership of timelines, and helping studies move efficiently from planning to execution.
You will:
Maintain study-specific and corporate startup tracking systems
Facilitate site budgets and contract negotiations
Support site regulatory document collection
Under supervision, may prepare initial/amendment submission dossiers to ethics committees, and/or site submission dossiers (as applicable)
Communicates with the project team and investigational sites throughout the study lifecycle
Develop site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
May review study specific translations
Responsible for maintaining the Trial Master File (TMF) for assigned tasks throughout the study lifecycle
📌 Study Startup Specialist I Sydney (Australia)
🏢 Psi Cro
📍 Australia