Premier Research is looking for a Clinical Research Associate II / Senior Clinical Research Associate to join our Clinical Monitoring team on a contract basis until at least June 2025.
This role will be fully home-based from Australia and contractors should, for travel purposes, be located in Sydney, Melbourne or Adelaide and possibly Brisbane. There will be an expectation for on-site monitoring across all states of Australia (including sites in Sydney, Perth & Melbourne) in addition to New Zealand (currently 1 site near Cambridge).
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What You’ll Be Doing:
- Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
- Scheduling site visits for monitoring as required by protocol monitoring visit windows.
- Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Planning day-to-day activities for study monitoring and setting priorities by site.
- Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Providing accurate and timely trip reports and records of hours worked.
- Managing query resolution with study sites and Premier Research data management operations.
What We Are Searching For:
Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional
Previous clinical research and independent site monitoring experience
Working knowledge of Australian and international regulatory procedures, and monitoring activities
You must be an Australian citizen or permanent resident visa holder in order to apply for this role.
Why Choose Premier Research?
Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
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