Clinical Trial Coordinator Organisation Context The Bionics Institute is passionate about multidisciplinary research and product development leading to clinical outcomes that improve lives. Our vision is to lead the world in innovative bionic health solutions through research, development, and translation. We are at an exciting phase, designing, implementing, and evaluating devices that assist in diagnosis and treatment of sensory deficits and neurological disorders. Our goal is to deliver benefits to people living with challenging health disorders by translating and commercialising our research outputs. The Institute’s Deep Brain Stimulation (DBS) research group has ongoing projects to translate clinical research findings into innovative devices to benefit patients living with Parkinson’s disease and related conditions. DBS is an established treatment for neurological movement disorders. It alleviates symptoms by delivering electric pulses via an implant to precise targets in the brain. We are developing techniques to assist surgeons in placing DBS electrodes precisely and to control chronic stimulation to optimise patient outcomes. We work closely with clinicians and have several commercial partners. The group is led by Professor Hugh McDermott and is based at the Bionics Institute in East Melbourne. Position Summary We are seeking a Clinical Trial Coordinator with an interest in biomedical engineering and neuroscience. As the successful applicant, you will work within a team of scientists, clinicians, engineers, and product developers to support clinical trials, support the safe and high-quality conduct of research, and produce reports in a timely manner. In this role you will have a unique opportunity to collaborate with the world-leading companies and to see your work translated directly into clinical practice. Duties and responsibilities: • Provide support for clinical trials involving Neuromodulation devices in hospitals• Support the Principal Investigator in fulfilling their clinical study responsibilities• Support the research clinicians through effective and timely management of clinical trials activities• Use Electronic Data Capture systems to appropriately manage clinical trial data• Assist with ethics requirements, including preparation of routine submissions to ethics committees and tracking the status of ethics permission.• Assist with maintenance of trial master file and sit files• Be the point of contact of for the Contract Research Organisation (CRO) managing the clinical trial• Assist with data collection/aggregation, data entry, and basic analysis• Support our safety and quality system with meeting record taking• Draft routine reports and/or assist with report generation and other group administration duties• Assess issues and escalate in the appropriate manner Qualifications and skills: • Minimum undergraduate qualifications in any of biomedical engineering, biomedical science, medical administration or nursing• Experience with clinical research,• Knowledge of the legislation and guidelines relating to human research in Australia including ICH GCP and The National Statement on Ethical Conduct in Human Research• Experience in dealing with Human Research Ethics Committees• Eligible to work in Australia• Highly effective working in a team, including consulting with skilled team members and other stakeholders to establish schedules and high-quality work practices• Proficient with using computers to collect and maintain data• Knowledge of biomedical applications and clinical workflow Qualities: • Passion for effective and ethical medical research• Interest in computer/engineering systems and the latest technology trends• Be a motivated self-learner with the ability to understand new techniques quickly• Be an empathetic and assertive communicator, able to participate in decision making with skilled and experienced team members• Have an analytical mind• Communicate complex procedures simply to others outside of the field• Good written and verbal communication• Attention to detail as well as initiative to explore and problem solve Knowledge The incumbent is expected to understand the requirements of the legislation and guidelines relating to human research in Australia including ICH GCP and The National Statement on Ethical Conduct in Human Research. They will have knowledge and experience in clinical research and dealing with Human Research Ethics Committees. The incumbent will have knowledge of biomedical applications and clinical workflow whilst been proficient with using computers to collect and maintain data. Problem Solving, Judgement The incumbent will have an analytical mind and a hands-on approach to identifying and proposing solutions in an appropriate manner. They will have an effective and ethical approach in decision making with skilled and experienced team members. The incumbent will be able to communicate complex procedures to the team and others outside of the field. Level of Supervision, Independence The incumbent will be Highly effective working in a team and stake holders. They are expected to be the point of contact for the Contract Research Organisation (CRO) managing the clinical trial, whilst general direction will be provided by the Supervisor. Interpersonal and Organisational Skills The incumbent will be motivated self-learner with the ability to understand new techniques quickly. They will need to be able to develop a quick rapport with a wide range of people, to communicate clearly and be able to have empathy with others. The incumbent will have a strong passion in computer/engineering systems, the latest technology trends and effective ethical medical research.This is a 2-year contract to 2023 with the possibility to renew (contingent on funding). Requirements: • The Bionics Institute requires that staff are vaccinated against COVID-19.• A police check is required. If you believe you meet the requirements for this position, please submit your application via SEEK. Please include a detailed CV, university transcripts, and a cover letter addressing the selection criteria. Applications close on Tuesday 2nd November 2021. For further information about the Clinical Trial Coordinator, please contact Dr Paul Minty by email: [email protected] Download full job description The Bionics Institute is an independent medical research institute affiliated with The University of Melbourne and is dedicated to translating into clinics life-enhancing treatments for neurological and sensory disorders. The Bionics Institute is an equal opportunity employer and female applicants are encouraged to apply. The Institute maintains a smoke free workplace and a workplace free from sexual harassment. The Bionics Institute’s workplace embraces the Occupational Health and Safety Standards.