Description
Study Start-Up Specialists in Australia focus on the early phases of clinical trials, ensuring regulatory and ethical approvals are secured efficiently for site activation.
Responsibilities
- Prepare and submit ethics and regulatory applications.
- Negotiate contracts and budgets with trial sites.
- Coordinate site initiation and training.
- Address start-up queries and ensure readiness for enrolment.
- Maintain start-up documentation and timelines.
Qualifications
- Bachelor’s degree in life sciences or healthcare.
- Experience with Australian ethics committees and TGA processes.
- Strong organisational and negotiation skills.
- Familiarity with clinical trial start-up workflows.