Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.
With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.
Make an Impact as a Senior Clinical Research Associate at Worldwide
As a Senior Clinical Research Associate, you will play a key role in ensuring the quality, integrity, and successful delivery of clinical research studies. Your expertise will help safeguard patient safety, maintain regulatory compliance, and support the generation of reliable data that advances clinical development.
In this role, you'll serve as a trusted partner to investigative sites, sponsors, and study teams, overseeing site activities from qualification through closeout. You'll help drive study success through strong site relationships, operational excellence, and a commitment to high-quality research.
You'll also have the opportunity to lead monitoring activities on global studies, mentor colleagues, contribute to process improvements, and make a meaningful impact on clinical development programs across multiple therapeutic areas.
Where You'll Work
This is a home-based Clinical Research Associate role based in Melbourne, Australia, supporting sites across Australia. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month.
To best support our sites, we're seeking candidates who are based in Melbourne, Australia. Travel will primarily be regional, with occasional travel to support sites in other locations as needed.
What You'll Do
- Lead site qualification, initiation, monitoring, and closeout visits in accordance with study protocols, ICH-GCP, and regulatory requirements.
- Serve as a Lead CRA on global studies, coordinating monitoring activities and providing guidance and mentorship to fellow CRAs.
- Evaluate site performance, protocol compliance, patient safety, and data quality through source document review and ongoing site oversight.
- Build and maintain strong relationships with investigative sites, providing training, support, and effective communication throughout the study lifecycle.
- Review clinical and regulatory documentation to ensure study records, ethics submissions, and Trial Master Files remain complete and inspection-ready.
- Partner with Project Management and cross-functional study teams to track milestones, assess deliverables, and support successful study execution.
- Drive data quality by reviewing CRFs, supporting query resolution, and overseeing investigational product accountability and site compliance.
- Contribute to study planning and operational excellence through monitoring plans, study tools, investigator meetings, training initiatives, and bid defense activities.
What You'll Bring
- Medical Doctor (MD), Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least 3 years of Clinical Research Associate experience; OR a bachelor's degree in a life science or related field with at least 5 years of Clinical Research Associate experience; OR a two-year college qualification or appropriate clinical training with at least 7 years of Clinical Research Associate experience.
- Extensive clinical research monitoring experience with strong expertise in site management and study oversight activities.
- Thorough knowledge of ICH-GCP, FDA and/or EU regulations, local regulatory requirements, and clinical research processes.
- Demonstrated experience across multiple therapeutic areas with the ability to function effectively as a Lead CRA.
- Strong leadership, mentoring, problem-solving, organizational, and time-management skills.
- Proficiency with Microsoft Office, electronic data capture (EDC) systems, and IxRS platforms.
- Valid passport and driver's license, with willingness to travel as required.
- Proficiency in English, both written and spoken.
- Experience in full-service monitoring PREFERRED.
Discover the Difference
We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.