Freelance Senior CRA: Command Trial Excellence Across Sydney & Melbourne
Your Mission: Be the On-Demand Expert for Clinical Trial Integrity
At ICON, we recognize that peak clinical trial performance requires peak expertise—available precisely when and where it's needed. As a Freelance Senior Clinical Research Associate (CRA), you will be that expert. This is a high-impact, flexible opportunity for seasoned professionals to deploy their deep monitoring and site management skills across priority studies in Sydney or Melbourne. You will step in as the trusted leader, ensuring sites operate with uncompromising quality, compliance, and efficiency. If you excel in autonomy, crave variety, and want to leverage your expertise on your terms, this freelance role is your gateway to shaping pivotal research.
We are seeking an independent, top-tier CRA who can immediately own site relationships and drive performance. You will be the crucial link between protocol and practice, safeguarding data integrity and patient safety across Australia's leading clinical research centres.
Your Impact: Own Site Performance & Drive Compliance
You will be the primary steward of clinical trial quality at assigned sites, responsible for end-to-end monitoring and site management to ensure flawless execution.
1. Conduct Expert Monitoring & Oversight
- 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 regulatory requirements (TGA).
- Proactively identify, document, and resolve complex site issues, implementing corrective and preventive actions to mitigate risks and keep trials on track.
- Conduct rigorous source data verification (SDV) and case report form (CRF) review to guarantee the accuracy, completeness, and timeliness of clinical data.
2. Lead Site Relationships & Development
- Build and maintain strong, collaborative partnerships with Principal Investigators and site staff, acting as their primary point of contact, trusted advisor, and problem-solving partner.
- Provide expert training and guidance to site personnel on study protocols, procedures, and GCP compliance, elevating site performance and competency.
- Facilitate smooth site operations by coordinating with cross-functional internal teams (clinical, data, safety) to ensure timely query resolution and data flow.
3. Ensure End-to-End Trial Integrity
- Manage all aspects of site management, including essential document collection, maintenance of the site Trial Master File (TMF), and ensuring sites are always inspection-ready.
- Prepare detailed monitoring reports, follow-up letters, and ensure timely and accurate documentation of all site interactions and findings.
- Contribute to site selection and feasibility assessments, leveraging your local knowledge of the Sydney/Melbourne clinical trial landscape.
Who You Are: An Autonomous Clinical Trial Authority
You are a self-sufficient professional who operates with the confidence of deep experience. You are adept at building instant rapport, navigating complexity, and delivering exceptional quality without direct oversight.
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 in Australia.
- Expert-level knowledge of ICH-GCP guidelines and Australian (TGA) clinical trial regulations and processes.
- Full proficiency with clinical trial software (EDC, CTMS, eTMF) and monitoring methodologies.
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance.
Your Core Professional Strengths
- Independent Leader: You thrive in a freelance model, managing your schedule, priorities, and site portfolio with exceptional organization and proactive communication.
- Expert Problem-Solver: You anticipate challenges, analyze complex situations, and implement effective, compliant solutions swiftly and independently.
- Influential Partner: You build trust rapidly with new sites and teams, navigating difficult conversations with diplomacy to ensure protocol adherence.
- Quality-Focused: You have an unwavering commitment to data integrity, patient safety, and regulatory compliance, serving as the ultimate quality check at the site level.
- Adaptable Professional: You seamlessly integrate into new study teams and adapt to different sponsor and therapeutic area requirements.
Why Choose Freelance Senior CRA with ICON?
Maximize Your Expertise & Flexibility
- Command Your Career: Enjoy the autonomy and flexibility of freelance work with the backing and resources of a global industry leader.
- High-Impact Engagements: Work on a variety of compelling, often complex studies across different therapeutic areas, keeping your skills sharp and your work engaging.
- Local Focus, Global Standards: Apply your deep local expertise in Sydney or Melbourne within ICON's world-class quality and operational framework.
Access Top-Tier Support & Resources
- #LI-Remote / #LI-JS1: Benefit from a hybrid model, performing remote monitoring where applicable while being locally available for essential site visits.
- Seamless Integration: Receive comprehensive study-specific training and be supported by dedicated ICON line and project management.
- Competitive Freelance Rate: We offer highly competitive remuneration that reflects your seniority and the critical value you bring to our trials.
Join a Culture of Excellence
- Even as a freelance professional, you are a valued part of our mission to shape the future of clinical development.
- Contribute to an inclusive, high-performance environment where your expertise is respected and pivotal to our success.
