Senior Clinical Trial Coordinator

Senior Clinical Trial Coordinator | Key Health Help Advance Medical Research That Makes a DifferenceKey Health Medical Centre is seeking an experienced and highly organised Senior Clinical Trial Coordinator to join our growing Clinical Research Unit (CRU) based in Sydney CBD South.This is an exciting opportunity for an experienced clinical research professional to take a senior role in the coordination and delivery of high-quality clinical trials.Working alongside experienced Research Nurses, Principal Investigators, Investigator GPs, sponsors and Contract Research Organisations (CROs), you'll play an important role in ensuring studies are delivered safely, efficiently and in accordance with protocol, Good Clinical Practice (GCP) and regulatory requirements.If you have strong clinical research experience, excellent attention to detail and enjoy taking ownership of multiple studies, we'd love to hear from you.About The RoleReporting to the Clinical Trial Manager, you'll take responsibility for the day-to-day coordination and delivery of multiple clinical trials across the Clinical Research Unit.You'll work closely with Principal Investigators, Research Nurses, sponsors and CROs, supporting studies from start-up through to close-out.As a senior member of the team, you'll also provide guidance and support to other members of the clinical research team and help maintain high standards across study delivery, documentation and compliance.Key ResponsibilitiesStudy CoordinationCoordinate and take ownership of day-to-day activities across multiple clinical trialsSupport and lead study start-up activities, including site initiation, feasibility activities and essential documentationCoordinate study timelines, milestones and site activities to ensure protocols are delivered within required timeframesSchedule participant visits and coordinate investigator and research nurse availability Maintain accurate, complete and audit-ready Trial Master Files (TMF/eTMF) and study documentationSupport monitoring visits, audits and regulatory inspectionsIdentify, manage and escalate study issues, risks and protocol deviations as requiredSupport study close-out activities and ensure all documentation is completed appropriatelyParticipant CoordinationSupport and coordinate participant recruitment, screening, enrolment and retention activitiesCoordinate participant appointments in accordance with study protocols and required timeframesMonitor participant progress, eligibility and retention throughout each studyWork closely with Research Nurses and investigators to ensure a positive participant experienceEnsure participant information and study documentation is maintained accurately and securelyRegulatory & ComplianceCoordinate and support ethics submissions, amendments, continuing reviews and safety reportingMaintain regulatory files, delegation logs, training records and other essential documentsEnsure study documentation is complete, accurate and inspection-readyEnter and maintain accurate study data within Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS)Ensure studies are conducted in accordance with ICH-GCP, TGA, HREC and sponsor requirementsIdentify compliance issues and work with the Clinical Trial Manager and investigators to address themSponsor & Stakeholder ManagementBuild strong working relationships with sponsors, CROs, Clinical Research Associates (CRAs) and study teamsAct as a key point of contact for day-to-day study coordination and site queriesRespond to data queries and study requests within required timeframesWork closely with Principal Investigators, GPs, Research Nurses and the Clinical Trial ManagerSupport study meetings and provide updates on recruitment, timelines, issues and study progressAssist with study administration, invoicing, ordering study supplies and maintaining accountability logsTeam Support & LeadershipProvide guidance and support to Clinical Trial Coordinators, Research Nurses and other members of the research team where requiredShare knowledge and support consistent clinical research processes across the CRU Assist with onboarding and training new team membersContribute to improving systems, processes and documentation within the Clinical Research UnitAbout YouYou'll be an experienced clinical research professional who is confident coordinating multiple studies and working with a range of internal and external stakeholders.You'll have strong attention to detail, excellent organisational skills and the ability to take ownership of your responsibilities.To be successful, you'll have:Previous experience as a Clinical Trial Coordinator, Senior Clinical Trial Coordinator, Clinical Research Coordinator, Research Nurse or similar roleExperience coordinating clinical trials within a medical centre, research site, hospital, CRO or similar environmentBachelor of Nursing preferred but candidates with other relevant science degrees will be consideredStrong understanding of ICH-GCP and clinical trial requirementsExperience working with clinical trial protocols, essential documents and regulatory requirementsExperience with EDC, CTMS and/or eTMF systemsExperience working with sponsors, CROs and CRAsUnderstanding of HREC and TGA requirementsStrong organisational and time management skills, with the ability to manage multiple studies and competing prioritiesExcellent communication and stakeholder management skillsHigh level of attention to detail and documentation accuracyConfidence working independently and taking ownership of study activitiesA proactive approach to identifying and resolving issuesCurrent GCP Certification will be highly regardedWhy Join Key Health?Be part of a growing Clinical Research Unit delivering meaningful medical researchTake ownership of a diverse range of clinical trialsWork alongside experienced clinicians, investigators and research professionalsOpportunity to develop your clinical research career in a senior capacitySupportive and collaborative team environmentModern Sydney CBD South locationOngoing learning and professional development opportunitiesIf you're an experienced clinical research professional looking for your next step and want to play a key role in delivering clinical trials that can improve patient outcomes, we'd love to hear from youApply now and join the Clinical Research Unit at Key Health Medical Centre.Key Health is an equal opportunity employer and welcomes applications from people of all backgrounds, experiences and identities.Prospective candidates will be required to provide proof of legal work rights and may be required to undertake relevant, role-appropriate pre-employment screening.If you require any reasonable adjustments to participate in the recruitment process at any stage, please let us know.