At a Glance
- Tasks: Manage clinical trial sites, ensuring compliance and performance throughout the study lifecycle.
- Company: Join a leading international clinical research organisation with a strong presence in Australia.
- Benefits: Competitive salary, flexible working arrangements, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for mentoring and career advancement.
- Why this job: Take ownership of impactful clinical trials and build relationships with key stakeholders.
- Qualifications: Experience as a CRA, strong knowledge of clinical research standards, and excellent communication skills.
The predicted salary is between 82800 - 101200 $ per year.
The Opportunity
We are supporting an international clinical research organisation looking to strengthen its Australian clinical operations team with an experienced Senior Clinical Research Associate.
The role will suit an established CRA who is confident managing Australian investigational sites independently and wants to take greater ownership across study delivery, site performance and stakeholder relationships.
Brisbane is the priority location, although experienced candidates elsewhere in Australia may be considered where they are comfortable travelling.
There is an active hiring need, with candidates who are immediately available or on a short notice period particularly encouraged to apply.
The Role
As a Senior CRA, you will take ownership of an assigned portfolio of clinical trial sites and act as a key link between investigators, study teams and sponsors.
Responsibilities will include
- Independently manage investigational sites throughout the clinical trial lifecycle.
- Conduct onsite and remote monitoring activities across start-up, initiation, active recruitment and close-out.
- Build strong working relationships with investigators and site teams.
- Monitor site quality, protocol compliance, patient safety and data integrity.
- Review source documentation and support the timely resolution of data and site-level issues.
- Monitor patient recruitment and site performance, identifying issues and supporting appropriate improvement plans.
- Ensure essential study and regulatory documentation is complete, accurate and inspection-ready.
- Oversee investigational product accountability and associated study materials.
- Identify potential risks early and work with internal teams and sites to implement appropriate corrective actions.
- Partner with Clinical Project Managers and wider study teams to ensure milestones and timelines are achieved.
- Provide clear updates on site progress, risks and performance to internal and external stakeholders.
- Support less experienced CRAs through mentoring and knowledge sharing.
- Depending on experience, take on additional responsibilities across study leadership and CRA oversight.
- What We’re Looking For
We are interested in experienced CRAs who can demonstrate
- Strong independent clinical trial monitoring experience.
- Experience managing Australian clinical trial sites with minimal supervision.
- Ability to manage sites across multiple stages of the clinical trial lifecycle.
- Strong knowledge of ICH-GCP and clinical research quality requirements.
- Confidence managing investigator and site relationships.
- Experience identifying, escalating and resolving site performance or compliance issues.
- Strong organisational skills with the ability to manage multiple sites and competing priorities.
- Excellent communication and stakeholder management skills.
- A relevant background in life sciences, nursing, pharmacy, health sciences or clinical research.
- Full Australian working rights, as visa sponsorship is not available.
- Ability to travel domestically as required.
- #J-18808-Ljbffr
Senior Clinical Research Associate employer: Planet Pharma
At Planet Pharma, we pride ourselves on being an exceptional employer, particularly for the Nurse Unit Manager - Clinical Trials role located in the vibrant Newcastle / Greater Sydney area. Our commitment to employee growth is evident through our supportive work culture that fosters collaboration and accountability, alongside competitive salaries and comprehensive benefits. With a focus on professional development and a strong emphasis on quality patient care, we offer a unique opportunity to lead a dedicated team in delivering impactful clinical research while enjoying the perks of working in a dynamic and award-winning environment.
