Site Start Up Associate - Australia
- Contract Type
Role: Site Start Up Associate
Contract Type: Permanent
Location: Australia - home based
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, dermatology, and rare diseases..
We’re looking for a talented and energetic Site Start Up Associate to join our team on a permanent basis. This role will be fully home-based, supported by an Australian manager.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
What will you be doing?
You will be responsible for performing country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, study-specific requirements and company policies and quality standards.
You will manage study start up activities to ensure accurate clinical and regulatory data within prescribed timelines; identify, resolve, mitigate, and escalate risks and issues; take responsibility for multiple studies; and work independently with team support.
You’ll be accountable and responsible for:
- Taking responsibility for quality deliverables for site start up, and following project requirements and applicable country rules
- Proactively forecasting submission/approval timelines and ensure adherence wherever possible. Provide clear communication with rationale for any delays and mitigate impact wherever possible
- Serve as primary point of contact for start-up in Australia to other project team members as required
- Assisting in all aspects of regulatory approval including preparation with sites for HREC and Governance/SSA applications and preparing and submitting CTN application forms. Preparing ongoing amendments and periodic/End of Study notifications as required.
- Assist with preparation, negotiation and finalisation of site contracts and budgets
- Ensuring accuracy and completeness of trial master file documents submitted during start-up and perform a QC review of files before transfer to maintenance for TMF filing
- Conduct other tasks and intelligence activities as required by the study team
- Works within the scope of the Clinical Management Plan, study processes, trial protocol, ICH-GCP/ISO14155, and customer requirements.
You’ll need this to be considered:
- Education: Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional
- Fluent verbal and written English
- Previous study start up experience
- Working knowledge of Australian and international regulatory procedures, and monitoring activities
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
- Happy to work fully home based
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