đ Accelerate First-in-Human Research: Study Start-Up Associate II (Home-Based, Australia)
Join ICON plc's Early Development team as a Study Start-Up Associate II and become the driving force behind pioneering first-in-human clinical trials. This home-based role across Australia positions you at the critical starting line of groundbreaking medical research, where your regulatory expertise will accelerate study initiation from the comfort of your home office.
As a world-leading healthcare intelligence organization, we're seeking a skilled start-up specialist to navigate Australia's regulatory landscape and launch early-phase clinical research. If you're passionate about regulatory compliance and thrive on bringing innovative studies to life, this is your opportunity to build a meaningful career while enjoying true work-from-home flexibility across Australia.
đŻÂ Your Study Start-Up Mission: Key Responsibilities
Regulatory Submission Excellence
- Lead preparation and submission of comprehensive regulatory documents including CTN/CTX applications, HREC submissions, and agency communications
- Coordinate with Australian HRECs and regulatory bodies to obtain essential approvals for study initiation
- Manage and maintain meticulous records of all regulatory submissions, approvals, and correspondence
- Ensure all documentation complies with TGA requirements, ICH-GCP guidelines, and local regulations
Stakeholder Coordination & Collaboration
- Coordinate and liaise with internal teams, investigators, and external stakeholders to secure necessary approvals
- Provide expert guidance and support to study teams on Australian regulatory requirements and start-up best practices
- Serve as primary point of contact for regulatory and ethics communications throughout start-up phase
- Facilitate effective information flow between sponsor, sites, and regulatory authorities
Process Optimization & Efficiency
- Participate in process improvement initiatives to streamline study start-up processes and enhance operational efficiency
- Implement best practices for document management and submission tracking in Australian context
- Contribute to the development of standardized start-up tools and templates for early-phase studies
- Identify opportunities to reduce start-up timelines while maintaining compliance excellence
Documentation & Quality Assurance
- Maintain comprehensive, audit-ready documentation for all start-up activities and regulatory interactions
- Ensure timely and accurate updates to study tracking systems and management reports
- Support the collection and organization of essential documents for investigator site files
- Conduct quality checks on submission packages before regulatory filing
â Your Profile: Study Start-Up Expertise
Essential Qualifications
- Bachelor's degree in Life Sciences, Health Sciences, or related field
- Minimum 2 years experience in clinical research or regulatory affairs with focus on study start-up activities
- Strong understanding of Australian regulatory requirements including TGA guidelines and HREC processes
- Knowledge of ICH-GCP guidelines and their application in Australian clinical research context
Regulatory Competencies
- Experience with CTN and CTX submission processes in Australia
- Familiarity with HREC submission requirements and ethics approval pathways
- Understanding of clinical trial notification and approval timelines in Australia
- Knowledge of state-specific requirements for clinical research site activation
Professional Attributes
- Excellent organizational skills with ability to prioritize and manage multiple tasks simultaneously
- Strong project management capabilities for coordinating complex start-up timelines
- Exceptional communication skills for effective collaboration with cross-functional teams
- Detail-oriented approach to regulatory documentation and compliance requirements
Home-Based Excellence
- Self-motivated professional capable of working independently in remote setting
- Strong time management skills for balancing multiple study start-ups
- Tech-savvy with proficiency in virtual collaboration tools and document management systems
- Ability to maintain productivity and focus in home office environment
đŤÂ Why Build Your Start-Up Career at ICON Australia?
Impact Early-Phase Research
- Play crucial role in launching first-in-human studies and early-phase clinical trials
- Contribute to bringing innovative treatments to Australian patients faster
- Work on cutting-edge therapeutic areas and novel treatment approaches
- Ensure regulatory compliance for groundbreaking medical research
Home-Based Flexibility
- 100% remote work opportunity from anywhere in Australia
- Modern technology infrastructure for seamless virtual collaboration
- Professional home office setup with ongoing IT support
- Balance work responsibilities with personal lifestyle preferences
Early Development Specialization
- Focus on high-impact early-phase clinical research
- Gain expertise in first-in-human study start-up requirements
- Exposure to innovative trial designs and novel therapeutic approaches
- Professional development in growing early-phase research field
Career Growth & Development
- Clear pathway to Senior Start-Up Associate and Regulatory Leadership roles
- Comprehensive training in Australian regulatory requirements and processes
- Opportunities for specialization in therapeutic areas or regulatory functions
- Global networking within ICON's international start-up community
Competitive ICON Australia Benefits
- Attractive salary package with performance incentives
- Comprehensive private health insurance for you and your family
- Global Employee Assistance Programme with local support
- Generous annual leave with Australian public holidays
- Competitive superannuation contributions and retirement planning
- Professional development allowance and certification support
- Home office equipment allowance and technology resources
đ Regulatory Areas You'll Master
- CTN/CTX Application Processes
- HREC Submission & Approval Pathways
- Site-Specific Assessment Requirements
- Regulatory Document Preparation
- Ethics Committee Communications
âąď¸Â Timelines You'll Accelerate
- HREC Approval Timelines
- Regulatory Submission Turnaround
- Site Activation Schedules
- Essential Document Collection
- Study Initiation Readiness
â¨Â Ready to Launch Groundbreaking Research?
If you're an experienced study start-up professional with knowledge of Australian regulations and passion for early-phase research, we encourage you to apply. This Study Start-Up Associate II role offers the unique opportunity to advance your career while accelerating the launch of innovative clinical trials from your home across Australia.
Apply Now and become ICON's next Study Start-Up expert in Australia!
