Emeritus Research is the most dynamic and exciting clinical trial centre in Australia and growing rapidly. Join our dynamic team as a Study Start-Up Specialist (we call it Trial Advancement) and be at the forefront of initiating and managing clinical trials, ensuring seamless study start-up processes.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. Being a fully on-site role, you will collaborate with cross-functional teams, liaise with regulatory authorities and drive the success of groundbreaking research projects.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 the 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 could look like when you join us:Working closely with our clients, meticulously prepare and negotiate budgets to achieve appropriate profit margins.Ensuring all necessary equipment is ordered and prepared ahead of study commencement for a smooth and efficient start.Streamlining and continuously improving processes to ensure effective and timely start up for every study.Developing and maintaining high quality relationships with clients and internal stakeholders, providing support throughout the start-up phase and, where required, after study activations.Implementing effective procedures to ensure all information entered is accurate and report outcomes are informative.Performing initial HREC submissions, maintaining and developing processes to reduce the number of HREC comments or queries.Attending trial specific start up meetings with sponsors/CROs to ensure a coordinated approach to TAT activities for each trial.Assisting the Operations Team with protocol amendments, document updates and reviews to ensure quality and accuracy is always maintained.Being detail orientated, pro-actively solving problems.Having fun with your team!To be successful for this role, we need you to:Be Adaptable to changing demands and prioritize effectively.Be exceptionally organised to ensure issues are resolved promptly and nothing is missed.Adhere to 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 qualifications 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.Keen to join the Team?If this sounds like an opportunity you cannot miss, send us your resume and cover letter detailing your experience and why you wish to join Emeritus Research - now!We look forward to meeting you!Please note, all applications will be assessed as they come in and we will only be contacting shortlisted candidates.
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