Senior Clinical Research Associate

The Melanoma Institute (MIA) is an independent, non - profit organisation located in North Sydney. The Institute is formally affiliated with the University of Sydney and collaborates with individuals at St Vincent's and Mater Health, Royal Prince Alfred Hospital and at the University of Sydney to improve the outcome of patients with melanoma. Each year around 1,200 new melanoma patients are referred to the Institute and approximately 12,000 follow-ups occur. Indeed, it has become a major referral centre for melanoma patients in NSW and overseas.

The Institute is seeking a Senior Clinical Research Associate (SCRA) to join our expanding investigator-initiated trials (IIT) team, whose studies are sponsored by Melanoma Institute Australia (MIA). This role offers opportunity to be involved in a diverse number of activities, with reduced travel compared to traditional CRA roles. Central to this SCRA role is the responsibility of leading the site-specific monitoring activities across the entire clinical trial lifecycle for a global phase III trial – from feasibility and start-up through to data-lock and close-out. The role also encompasses the mentoring of junior CRAs, shaping SOPs and guiding the improvement of internal processes.

The SCRA will support the Chief Investigators, Clinical Trials Operations Manager and the research team in the delivery and implementation of Investigator Initiated Trials (IITs) within an academic/not-for-profit setting. Pivotal to the role will be both national and international site set-up, engagement and management, undertaking training of the investigational site personnel, source document verification activities, supporting sites to maintain research governance approvals and an overall assurance that the conduct of the trial is in accordance to the study protocol and regulatory requirements. There will also be a strong emphasis on building collaborative relationships between a large number of stakeholders. The SCRA also has opportunity for progressing the development of key clinical study documents such as the protocol and patient informed consent form and to support the work required in ethics submissions. They will also be involved in the mentoring and training of junior CRAs that are working to support the trial, so will have far reaching impact via this role.

Key Selection Criteria:

• To succeed, you will need to have at least 2 years of experience as a SCRA, and greater than 5 years working within clinical research.
• Experience in initiating multicentre trials is essential, and exposure to international trial start-up would be highly regarded.
• Proven capability in source data verification, protocol adherence and trial documentation with experience in risk-based and remote monitoring activities.
• Excellent communication skills with an ability to engage varied stakeholders and provide concise, clear information.
• Strong operational and planning skills in order to prioritise conflicting deadlines and ensure timelines are met.
• Demonstrate flexibility in navigating changing priorities with an ability to move seamlessly between varied tasks.
• Must be accurate with an excellent attention to detail and a methodical approach to work.
• Ability to work well in a dynamic, project team.
• Excellent conceptual thinking skills and a positive, pro-active attitude to resolving problems.
• Strong knowledge of the regulatory legislation surrounding clinical trials, ICH-GCP and associated protocols
• Excellent computer skills in MS Office applications, particularly in Word, Excel and Outlook. Previous experience in the use of REDCap databases would be an advantage.

This is an outstanding opportunity to further your career and develop your skills in a globally recognised institution. You will enjoy achieving outcomes across all stages of the clinical trials, and will find great satisfaction in supporting cancer research projects.

If this role sounds like a suitable fit for you, please send us your CV and a cover letter addressing your experience as per outlined in this advertisement.

Only applicants with full working rights within Australia should apply. Only successful applicants will be contacted. Please no recruitment agencies.

Application will close on 13 October 2025. Due to the overwhelming response, we will only be contacting candidates we wish to interview.

As we are considered a health facility, for us to accept your application, you must be fully vaccinated against COVID-19.

We pay our respects to the Traditional Custodians of the lands on which Melanoma Institute Australia works, and their Elders both past and present, and acknowledge the deep, continuing connection of Aboriginal and Torres Strait Islander peoples to the land, waters, and sky.