🌏 Accelerate Clinical Research: Site Partner II - Australia (Home-Based)
Join ICON plc as a Site Partner and become the strategic catalyst for efficient clinical trial activation across Australia. This home-based role empowers you to build strong partnerships with research sites, drive rapid study start-up, and deliver exceptional experiences that accelerate medical breakthroughs from anywhere in Australia.
As a world-leading healthcare intelligence organization, we're seeking an experienced site activation specialist to optimize clinical trial timelines and build lasting relationships with Australian research sites. If you're passionate about streamlining processes and thrive on delivering operational excellence, this is your opportunity to shape the future of clinical development while enjoying true home-based flexibility.
🎯 Your Site Partnership Mission: Key Responsibilities
Site Activation Leadership
- Lead proactive coordination of all tasks required for timely site activations and ongoing maintenance across assigned Australian research sites
- Act as primary site liaison and escalation point, resolving challenges promptly while ensuring exceptional site experiences
- Partner closely with site teams to accurately forecast Site Activation and Critical Document Package (CDP) approval timelines
- Capture risks and implement mitigation strategies within ICON systems to ensure timeline adherence
Documentation Excellence
- Collect, quality-check, and prepare all Critical Document Package materials in compliance with ICON SOPs, ICH/GCP, and Australian regulatory requirements
- Ensure complete, accurate Trial Master File (TMF) documentation that meets sponsor expectations and audit readiness standards
- Support ethics/IRB submissions and manage Australian regulatory requirements including HREC approvals
- Prepare, adapt, and customize Informed Consent Forms while coordinating required translations
Strategic Collaboration
- Build strong working relationships with key functional partners including Project Managers, CTMs, Regulatory leads, and third-party vendors
- Drive site start-up timelines with accuracy, urgency, and forward-thinking planning
- Escalate risks early and provide clear contingency plans to maintain project momentum
- Support Clinical Trial Agreement negotiations while maintaining proactive site communication
Process Innovation
- Serve as Subject Matter Expert in site activation processes, staying current with evolving Australian regulatory requirements
- Contribute to process improvements and technology initiatives that enhance site and customer experiences
- Participate in site selection and qualification activities to optimize research site partnerships
- Ensure timely, accurate entry of all site status updates into tracking and management systems
⭐ Your Profile: Site Activation Expertise
Essential Qualifications
- Solid working knowledge of ICH-GCP, Australian regulatory requirements, and clinical research SOPs
- Strong organizational skills with proven ability to manage multiple priorities and drive outcomes
- High attention to detail with commitment to quality, accuracy, and documentation excellence
- Outstanding communication and stakeholder management capabilities
Professional Experience
- Experience in clinical trial start-up, site activation, or related role within CRO or sponsor environment
- Understanding of Australian HREC submissions and state-specific regulatory requirements
- Familiarity with Clinical Trial Agreement negotiations and site budget considerations
- Experience with electronic TMF systems and clinical trial management platforms
Key Competencies
- Proactive Mindset: Solutions-focused approach with confidence in escalating issues early
- Relationship Building: Strong interpersonal skills for developing trusted site partnerships
- Process Optimization: Ability to identify and implement efficiency improvements
- Regulatory Acumen: Understanding of TGA requirements and Australian research guidelines
Technical Skills
- Proficiency with clinical trial management and document tracking systems
- Experience with Informed Consent Form preparation and adaptation
- Knowledge of site qualification and selection processes
- Familiarity with Australian clinical research ecosystem and site landscape
💫 Why Partner with ICON Australia?
Impact Australian Clinical Research
- Play pivotal role in accelerating clinical trial activation across Australia's research institutions
- Contribute to making innovative treatments more accessible to Australian patients
- Build strong partnerships with leading Australian research sites and investigators
- Drive efficiency in Australia's growing clinical research landscape
Home-Based Flexibility
- 100% remote work opportunity from anywhere in Australia
- True work-life balance with flexible scheduling options
- Modern technology infrastructure for seamless virtual collaboration
- Avoid commute while maintaining high-impact professional contribution
Career Growth & Development
- Clear pathway to Senior Site Partner and Site Activation Leadership roles
- Exposure to diverse therapeutic areas and complex study designs
- Opportunities for professional certification and specialized training
- Global networking within ICON's international site activation 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 24/7 support
- Generous annual leave with Australian public holidays
- Competitive superannuation contributions and retirement planning
- Professional development allowance and training opportunities
- Home office setup support and technology resources
✨ Ready to Accelerate Clinical Trials Across Australia?
If you're an experienced site activation professional with knowledge of Australia's clinical research landscape and passion for building strong site partnerships, we encourage you to apply. This Site Partner role offers the unique opportunity to advance your career while driving efficiency in clinical trial activation across Australia.
Apply Now and become ICON's next Site Activation expert in Australia!
