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Join to apply for the Senior Clinical Research Associate role at The George Institute for Global Health2 weeks ago Be among the first 25 applicantsJoin to apply for the Senior Clinical Research Associate role at The George Institute for Global HealthOur mission is to improve the health of millions of people worldwide.Full Time Opportunity (5 days per week)Barangaroo, Sydney CBD (Relocation to Randwick in September, 2025)24 Months Fixed Term ContractHybrid working environmentPro-Rata Salary Range of $94-100k Base Base (dependent on experience, skills and capabilities) plus 11.5% Superannuation + Smart Salary Packaging BenefitThe Senior Clinical Research Associate (SCRA) will support the Project Manager (PM) in the development and execution of various research projects (clinical and /or non-clinical trials) within the academic research programs of work, priority based on business requirements at that time.In addition to site management responsibilities, the SCRA will support the PM on project management-related tasks allocated to them. The scope and level of responsibility is negotiated between the SCRA and PM. In conjunction with the PM, the SCRA ensures that these research projects are performing according to the quality standards and deadlines required.Key Responsibilities and Duties:Participate in the clinical trial feasibility assessment, identify and selects investigators with the PM.Site management responsibilities:Prepares and ensure the Human Research Ethics Committee (HREC) and relevant Regulatory submissions are completed within the project timelines.Prepares/collects all documents needed prior to study initiation.Conducts site initiation meetings to ensure compliance with SOPs and all study specific and regulatory requirements are met.Develops and maintains a good working relationship with the Investigational site staff.Management of the local study files, including in-house and site filePrepares, organises and participates in, Investigator meetings.Site managementConduct on site and remote monitoring of participating centres to ensure:Quality, accuracy, completion, and timeliness of data entry.Complete and efficient resolution of data issues and audit findings.Adherence to the study protocol and study procedures manual.Adherence to ICH-GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of adverse events/serious adverse events are reportedComplete all monitoring visit and progress reports accurately and within study specified timeframe.Collect and review essential documents from study sites and ensure they are complete at study close-out and appropriately stored/managed in-house.Overseas regional co-ordinating centre managementManage and assist regional coordinating staff in the local management of the study where required.On occasion, conduct co-monitoring with regional coordinating centre staff to ensure adherence to study protocol and study procedures manualReview and sign-off monitoring visit reportsQuality, accuracy and completeness of dataEnsure adherence to regulatory requirements e.g. ICH-GCP, SOPsAssist project team to deliver clean, accurate and verifiable data for final analysesFile and archive clinical study data at end of projectEnsure patient safety and adverse/serious adverse events are reported according to regulatory requirementsWhere applicable liaise with staff in Data Management and Statistics programs on project specific deliverablesProject Management Delegated Tasks:The SCRA may be asked to support the PM on project management-related tasks including:Developing tracking, monitoring and filing systemsDeveloping investigator payment tracking systemDeveloping project-specific documentsInvestigational product managementManages project related logisticsData management support of research projects.All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH-GCP (if applicable) and applicable regulatory requirements.For more information on this role, please see our detailed Position Description hereSkills, Knowledge and Experience/ Our Successful CandidateTertiary qualifications in a related science or health care disciplineAt least 2 years of monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment.Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regionsUnderstanding of medical terminologyExcellent knowledge of ICH-GCP guidelinesUnderstanding of confidentiality and privacy laws and all guidelines relevant to medical researchExcellent skills in MS Office applications including Excel and WordExcellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholdersStrong focus on producing the highest quality of work and on ensuring optimum accuracy of outputsAbility and willingness to travel.Experience working on oncology randomized controlled trialsClosing DateThe closing date for applications is 9th July, 2025We reserve the right to close this vacancy early if a suitable candidate is foundThe unrestricted right to work in Australia is a requirement for this position. Candidates who require sponsorship will not be considered.About the GeorgeThe George Institute for Global Health(The George) is 700+ employees around the world and projects in over 40 countries all focused on improving the health of millions of people worldwide.As a medical research institute affiliated with leading universities, we are challenging the status quo in healthcare to:Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare deliveryLook beyondsingle diseases, across the life course,to identify patient-centred approaches to care that can be implemented at scaleDevelop low-cost, innovative solutions to global unmet needsDrive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurshipWe pride ourselves with our 6 core values: excellence, integrity, can-do approach, creativity, impact, and humanitarian commitment.Please visit our website for more on The George: Home | The George Institute for Global HealthOur big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work.We value workplace diversity and encourage applications from people living with disability; women; Aboriginal and Torres Strait Islander people; people who identify as LGBTIQ+; mature-aged people and those from culturally and linguistically diverse backgrounds.Why The George?We are committed to attracting, developing, rewarding and retaining the best people in their fields to conduct and support our innovative and highest quality research programs.Take advantage of our rewards you may enjoy as part of The George team.Generous salary packaging benefits increasing your take home payLearning and career development opportunitiesExtra leave days including extended Christmas break and study leaveYourFlex arrangements e.g. start/finish times, purchase leave, locationA global, diverse, inclusive team committed to making impactSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionResearch, Analyst, and Information TechnologyIndustriesResearchReferrals increase your chances of interviewing at The George Institute for Global Health by 2xGet notified about new Senior Clinical Research Associate jobs in Sydney, New South Wales, Australia.Clinical Trial Coordinator (Research Nurse)Darlinghurst, New South Wales, Australia 2 weeks agoSt George Hospital - Clinical Research Manager - Medical Oncology and Radiation OncologySydney, New South Wales, Australia 2 months agoSydney, New South Wales, Australia 4 days agoClinical Trial Coordinator (Research Nurse)Sydney, New South Wales, Australia 2 weeks agoMacquarie Park, New South Wales, Australia 2 days agoAboriginal and Torres Strait Islander Health Research LeadSydney, New South Wales, Australia 2 weeks agoClinical Education Academic in Small Animal SurgerySydney, New South Wales, Australia A$122,830.00-A$199,585.00 3 weeks agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 1 month agoSydney, New South Wales, Australia 1 month agoClinical Research Associate/Senior Clinical Research AssociateMacquarie Park, New South Wales, Australia 2 days agoSenior / Clinical Research Associate (Biopharma)Macquarie Park, New South Wales, Australia 2 days agoNorth Sydney, New South Wales, Australia 3 days agoSenior / Clinical Research Associate (Oncology)Macquarie Park, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 3 days agoClinical Research Associate - CRA Australia (Level Depending on Experience)Sydney, New South Wales, Australia 2 months agoSydney, New South Wales, Australia 3 days agoClinical Research Associate II: Bring your career to life at Fortrea!Sydney, New South Wales, Australia 5 days agoSydney, New South Wales, Australia 3 weeks agoNorth Sydney, New South Wales, Australia 3 days agoSenior Clinical Research Associate (GC CRO)Senior Clinical Research Associate (GC CRO)Sydney, New South Wales, Australia A$200,000.00-A$250,000.00 4 days agoSenior Clinical Research Study Coordinator - REQ586057Westmead, New South Wales, Australia 3 days agoSt Leonards, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia A$31.72-A$35.72 3 days agoSenior Clinical Research Study Coordinator - Cancer Centre for Children - REQ589066Westmead, New South Wales, Australia 3 days agoSydney, New South Wales, Australia 2 weeks agoWere unlocking community knowledge in a new way. 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