Study Start Up Specialist

Emeritus Research is leading the way in clinical trials, known for our innovation, energy, and commitment to excellence. We're currently seeking a passionate and experienced Study Start-Up Specialist to become a key member of our dedicated Trial Advancement Team.

If you're ready to make a meaningful impact in a fast-paced, high-performing environment—apply now and help shape the future of clinical research.

About us:

Emeritus Research improves world health and accelerates medical advancements by expertly managing clinical trials. We work with top global Pharmaceutical and Biotechnology companies and have facilitated a myriad of trials that have brought today's leading medications to market.

Being privately owned by an ambitious and supportive Board, we have the flexibility to be innovative, and pivot when required. Over the past six years, Emeritus Research has seen exponential growth in capacity, staffing, and trial opportunities. We have a nimble approach to trial implementation, whilst ensuring safety and quality are delivered in our services.

Emeritus has diversified roles within the company to ensure every step of the trial is approached with expertise. Every team member is valued for their contribution and solution focused approach.

About the role:

With a constant focus on quality and professional service to our clients, the Trial Advancement Team is responsible for the effective set-up of each clinical trial at all Emeritus Research sites and accountable for reaching trial activation milestones.

Specifically, the role:

• manages new clinical trials from formal selection until the study is handed to the Operational Team
• is the primary contact, facilitating communication between the client, our clinical, operational and support teams to ensure a smooth start-up process and successful management of the trial
• enhances each study's success by ensuring all start-up activities are completed including HREC submission and approval, budget and client negotiation documents, vendor set-up, essential document management, preparation of on-line systems and creation of source notes and clinical site files
• creates the springboard for successful trials to support Emeritus Research attain our financial and operational goals.

What your day will look like:

• Develop and maintain high quality relationships with clients and internal stakeholders to provide support throughout the study start up and, where required, after study activations
• Implement effective procedures to ensure all information entered is accurate and report outcomes are informative
• Streamline and continuously improve processes to ensure effective and timely start up for every study
• Maintain and develop processes to reduce the number of HREC comments on consent forms
• Attendance at trial specific start up meetings with sponsors/CROs to ensure a coordinated approach to TAT activities for each trial
• Assist the Operations Team with protocol amendments, document updates and reviews to ensure quality and accuracy is always maintained

To be successful for this role, we need you to:

• Be Adaptable to changing demands and prioritise effectively
• Be exceptionally organised to ensure issues are resolved promptly and nothing is missed
• Adhereto processes and guidelines set by Emeritus Research and other external parties such as HREC and governance committees.
• Be Confident in reading complex documents such as protocols and contracts
• Organise and manage large amounts of files, tasks, schedules, and information
• Possess detail-oriented qualities to ensure accuracy with all work performed.
• Constantly lookout for ways to improve our processes and results

You will bring:

• 2+ years of clinical research experience, preferably in study start-up
• Tertiary qualification in Nursing, Medicine, Science (or equivalent) is preferred but not essential
• Sound knowledge of the regulatory processes
• Demonstrated computer skills in Microsoft Office
• Excellent oral and written communication skills
• Australian Citizen or Permanent Resident

Is this your next career step?

Then, send us your resume with a cover letter outlining why this is your next job.

We look forward to hearing from you