Senior Clinical Research Associate (CRA) – Hybrid, Sydney
Your Mission: Be the Strategic Leader for Clinical Trial Excellence in Australia
At ICON in Sydney, our clinical trials are critical pathways to new medical breakthroughs. As a Senior Clinical Research Associate (CRA), you will be the strategic leader and primary guardian of trial integrity at the site level. This hybrid role offers the perfect balance of remote analysis and on-site leadership, where your deep expertise in monitoring and site management will ensure studies are executed with uncompromising quality, compliance, and efficiency across Australia. You will not just monitor sites; you will elevate them, acting as a trusted advisor to investigators and a pivotal leader within our global study teams.
We are seeking an accomplished, autonomous CRA to take ownership of a portfolio of complex sites. If you are driven by operational excellence, excel at building influential relationships, and are ready to mentor others while delivering best-in-class monitoring, this hybrid role based in Sydney is your platform to advance your career.
Your Impact: Lead, Mentor, and Ensure Uncompromising Quality
You will be the accountable expert for site performance, responsible for the end-to-end oversight that guarantees data integrity, patient safety, and regulatory compliance.
1. Conduct Expert Monitoring & Proactive Site Leadership
- Perform comprehensive remote and on-site monitoring visits (pre-study, initiation, routine, and close-out) to ensure strict adherence to protocols, ICH-GCP, and Australian (TGA) regulatory requirements.
- Proactively identify, document, and resolve complex site issues, implementing effective corrective and preventive actions to mitigate risks and keep trials on track.
- Conduct rigorous source data verification (SDV) and manage the timely and accurate resolution of data queries.
2. Build Influential Partnerships & Drive Site Excellence
- Build and maintain strong, collaborative partnerships with Principal Investigators and site staff, acting as their primary point of contact, strategic advisor, and problem-solving partner.
- Provide expert training, guidance, and mentorship to site personnel and junior CRAs, elevating site competency and fostering a culture of quality and compliance.
- Serve as the key liaison between the site and cross-functional internal teams (project management, data management, safety), ensuring seamless communication and issue escalation.
3. Own Site Management & Trial Integrity
- Manage all aspects of site management, including essential document collection, maintenance of the site Trial Master File (TMF), and ensuring sites are perpetually inspection-ready.
- Prepare detailed monitoring reports and follow-up letters with clear, actionable items.
- Contribute to site selection and feasibility assessments, leveraging your deep knowledge of the Australian clinical trial landscape.
- Ability and willingness to travel approximately 60% of the time domestically and potentially internationally, with a valid driver’s license.
Who You Are: An Autonomous Clinical Trial Authority
You are a seasoned professional who operates with confidence and independence. You are a natural leader, adept at building trust, navigating complexity, and driving sites to exceed expectations.
Your Proven Foundation
- Bachelor’s or advanced degree in Life Sciences, Nursing, Medicine, or a related field.
- Extensive experience as a Senior CRA (typically 5+ years), with a proven track record of independently managing multiple, complex clinical trial sites, preferably within the Australian market.
- Expert-level knowledge of ICH-GCP guidelines and Australian (TGA) clinical trial regulations.
- Full proficiency with clinical trial software (EDC, CTMS, eTMF) and monitoring methodologies.
- Excellent communication, interpersonal, and stakeholder management skills, with a proven ability to influence and drive compliance.
- Must possess a valid driver’s license and be willing and able to travel as required for the role.
Your Core Leadership Strengths
- Strategic Site Manager: You see beyond checklist monitoring to develop strategic, risk-based plans that optimize site performance and data quality.
- Influential Leader & Mentor: You build trust effortlessly, mentor colleagues, and guide sites with a balance of support and accountability.
- Proactive Problem-Solver: You anticipate challenges and implement effective, compliant solutions swiftly and independently.
- Hybrid Work Expert: You excel at managing your time between remote administrative work, data review, and impactful on-site presence.
- Quality & Detail Focused: You have an unwavering commitment to data integrity, patient safety, and regulatory compliance.
Why Advance Your Career as a Senior CRA at ICON in Sydney?
Master Your Craft with Autonomy & Impact
- Hybrid Flexibility: Benefit from a balanced model that combines focused remote work with essential on-site collaboration and monitoring across Australia.
- Portfolio Ownership: Take full accountability for key sites within high-profile, often complex clinical studies across diverse therapeutic areas.
- Career Leadership Pathway: This senior role is a direct gateway to further leadership positions such as Lead CRA, Clinical Team Manager, or Project Management.
Thrive in a Supportive, Global Culture
- Join a diverse and inclusive culture that values deep expertise, strategic thinking, and provides the tools and global support for you to succeed.
- Be part of our mission to shape the future of clinical development within a premier global CRO.
Competitive ICON Benefits in Australia
- We offer a highly competitive salary and performance-based bonus structure.
- Receive a comprehensive benefits package including premium health insurance, generous annual leave, and robust retirement planning.
- Benefit from our global Employee Assistance Programme (EAP) and a strong commitment to your continuous professional development.
