Take your career to the next level and lead challenging study activation process in Australia. You will support clinical research teams and ensure PSI projects start smoothly and on time.
We鈥檙e looking for a SSU Specialist Ion an 18-month contract to support our increased workload. This is a great opportunity for someone looking to gain hands-on experience in clinical research. This role is to be based in Sydney.
You will:
- Maintains study-specific and corporate startup tracking systems
- Facilitates site budgets and contract negotiations
- Supports site regulatory document collection
- Under supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
- Communicates with the project team and investigational sites throughout the entire duration of the study
- Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
- May review study specific translations
- Supervises Trial Master File (TMF) maintenance throughout the study startup phase