Senior Trial Operations Coordinator

• Full time, 2 years fixed term
• Exciting opportunity for a Senior Trial Operations Coordinator to join the Clinical Trials Operations team at the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, located at Medical Foundation Building or Chris O’Brien Lifehouse, Camperdown Campus
• Base Salary $108,557-$118,267 + 17% superannuation

About the opportunity

The NHMRC Clinical Trials Centre (CTC) is a flagship academic research organisation within the University of Sydney. The CTC develops and conducts large, multicentre, and international investigator-initiated clinical trials, commonly in collaboration with national and international research groups, and contributes expertise to trials run by others. The research conducted by the CTC covers a broad range of therapeutic areas including oncology, cardiology, diabetology, nephrology, neonatal and perinatal health, and currently a number of exciting projects investigating treatments for COVID-19.  Our clinical operations team plays a key role in the delivery of high-quality academic research.

 The CTC employs over 260 staff who share a combined passion for high quality clinical trials and research. We encourage collaboration and innovation, and our staff work closely across all levels to share experience, knowledge, and ideas. We provide a highly supportive, inclusive and flexible work environment. We encourage those with a can-do attitude, looking to take on a new challenge, to apply.

We are seeking applicants to cover a number of roles across our growing academic research organisation. The Senior Trial Operations Coordinator contributes their expertise within clinical trials and impacting the immediate outcomes of the clinical trial(s) they are responsible for.

Your key responsibilities will be to:

• perform clinical trial activities, including preparing trial procedures, setting up and organising clinical trial sites, reporting on trial milestones, on-site monitoring, supporting junior trials staff, archiving documents and correspondence, work under the supervision of the Clinical Trial Operations Leads and/or Program Managers
• working in collaboration with internal and external stakeholders, including clinical trial funders, research collaborators, project team members, functional leads and CTC senior managers
• provide high level clinical trial knowledge and expertise to the Site Investigators, Site Coordinators and the research team to support the clinical trial requirements
• assist with selecting sites, coordinating ethics committee and regulatory authority applications, supervising trial supplies and organising/ attending investigator meetings
• provide administrative and other support tasks associated with clinical trials and other research projects.

About you

• undergraduate (BSc) or higher degree in scientific, (bio) medical or health discipline with subsequent relevant experience; or an equivalent combination of relevant experience and education/training.
• extensive relevant working experience in clinical site management, as trial operations coordinator, senior/lead clinical research associate, project officer, senior trial coordinator, or similar role
• knowledge of clinical trial requirements during their lifecycle from start up to close out, including a detailed understanding of the regulatory and ethical approval process across Australia
• thorough knowledge of ICH Guidelines and Good Clinical Practice
• excellent time and workload management skills with demonstrated ability to prioritise effectively, manage multiple tasks, meet deadlines and achieve required outcomes
• ability to maintain high work standards with minimal supervision, and ensure that other team members maintain and implement SOPs
• excellent interpersonal, verbal and written communication skills with sound negotiating and conflict resolution skills and a demonstrated level of tact and discretion in dealing with day to day operational matters
• financial management experience and literacy, experience in managing and tracking site/vendor payments against contract
• high level computing skills (including databases in a windows environment, spreadsheets and word-processing).

To keep our community safe, please be aware of our COVID safety precautions which form our conditions of entry for all staff, students and visitors coming to campus.

Sponsorship / work rights for Australia