
Clinical Trials Study Coordinator
2 days ago
Introduction:About us:Sinclair Dermatology is a globally recognised medical centre headed by internationally renowned Dermatologist, Professor Rodney Sinclair.
We see over 10,000 patients a year and house Australia's largest Dermatology research and clinical trials centre (Sinclair DIRECT).
Our main office is conveniently located in East Melbourne with another two sites in Parkville and Pascoe Vale South.We have an exciting opportunity for a Full-time Clinical Trials Coordinator.Description:Position DescriptionWith team fit a priority, we are seeking an experienced and motivated Clinical Trials Coordinator to join our team.
Your supportive and empathetic approach along with your ability to listen to patients will be critical to your success in this role.Reporting to the Unit Head, the Clinical Trials Coordinator will support investigators to run clinical trials according to the research protocol, ICH-GCP Guidelines, applicable regulatory and local requirements.
This role will ensure the day-to-day running of delegated clinical trials in a manner that supports investigators, clinicians, patients and their team.The roleYou will be responsible for but not limited to the following duties:Attend Site Initiation Visits (remote and on-site) for delegated trialsPrepare for and host site initiation, monitoring and close out visitsPrepare and conduct participant visitsCo-ordinate all aspects of allocated clinical trialsComplete associated documentation, maintain study binders and other relevant documentationMaintain investigational product and perform accountabilityMaintain open and regular communication with Sponsors, CRAs and monitorsComplete all study close out activities including archiving of all study recordsWork with the recruitment team to ensure recruitment targets and timelines are metEnsure studies are performed in accordance with GCP guidelines, NHMRC standards, the Australian Safety and Quality Framework for Health Care, relevant Australian laws and regulations, site Standard Operating Procedures (SOPs) and study protocols.Selection CriteriaEssentialAppropriate tertiary qualifications (eg. Science, Pharmacy or related disciplines) will be consideredExperience working as a Clinical Trials Co-ordinator is desirableSound understanding of clinical trials and good understanding of clinical trial phasesSound understanding of the National Statement on Conduct of human research, OHMR policies and guidelines, Privacy and Good Clinical Practice relating to the ethical conduct of human researchHigh level of attention to detailBe committed to the smooth running of clinical trials within your portfolioAbility to handle multiple tasks and prioritise effectivelyAbility to work efficiently and effectivelyFamiliarity with office-based computer packages, such as Microsoft Word, Excel, Outlook and other relevant software.Demonstrate excellent time management skillsTeam playerDemonstrated high-level oral and written communication skills.Has an empathetic and supportive approachAdditional BenefitsSupportive team environmentFlexible working hoursImmediate startRewarding industryStaff discountsConveniently located office within 2 train stations, buses, and tramsEAPPrevious applicants do not need to reapply.Open to Australian Residents Only.
Shortlisted candidates will only be contacted.
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