Job Title

Senior Clinical Research Associate, AustraliaAt Emerald Clinical Trials, we are a global, fullservice Contract Research Organization (CRO) with a rich heritage in the AsiaPacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to postmarketing.Our therapeutic expertise spans renal, cardiometabolic, and oncologyareas where we make a significant impact on improving global health.At the heart of our success is our ability to combine global reach with local knowledge. Our ontheground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster resultsbringing therapies to patients in need.About the RoleThe Senior Clinical Research Associate (SCRA) is a member of the Clinical Operations group at Emerald Clinical. The group is responsible for site management, monitoring tasks, and the operational support of clinical trials. The group allocates resources to projects as appropriate to assist with the implementation of project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).ResponsibilitiesCoordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.Complete all monitoring activities per the Monitoring Plan and produce monitoring visit reports accurately and within the predetermined timeframe.Prepare, plan, organise, and conduct site evaluation visits and report on these visits to assist with site selection.Prepare, submit, and/or liaise with regulatory specialist colleagues regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.Prepare, plan, organise, and conduct site initiation visits.Develop and maintain appropriate monitoring tools and projectspecific documents.Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so that they can fulfil their obligations accurately and to deadlines.Manage trial sites utilising both onsite and offsite activities including:Verification of quality, accuracy, completion, and timeliness of data.Ensure complete and efficient resolution of data queries, audits, issues, and liaison with Data Management and/or Quality colleagues, as needed.Adhere to the trial protocol, all applicable projectrelated plans, as required by the project training matrix, and other relevant projectspecific requirements.Adhere to ICH/GCP and other regulatory guidelines and requirements, including reporting of subject safety adverse/serious adverse events, protocol violations/deviations, and liaison with safety colleagues as needed.Ensure targets, metrics, and quality are maintained per trial expectations.Identify risks associated with e.g., clinical trial design, privacy and confidentiality, clinical trial misconduct, and take action to mitigate risk proactively and to escal as appropriate.Collect, review, and approve essential documents from trial sites to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.Reconcile contents of the inhouse TMF and site''s Investigator Site Files.Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.Support strategies to boost recruitment efforts.Coordinate and perform translation verification of regional language as required or applicable per region.Perform site closeout visits and other site activities including archiving, as applicable.Mentor, coach, and train junior staff members as directed by line management.Perform any additional responsibilities assigned by the Line Manager and/or Project Lead.About YouEducated to degree level in pharmacy, medical, nursing, biological science, or other healthrelated disciplines (preferred) or equivalent relevant experience. 5 years experience preferred, 4 years may be considered based on relevant experience in clinical trial monitoring and/or site management within an academic, contract research organization, or pharmaceutical environment.Must have at least 2years onsite monitoring experience in the field of OncologyTechnical competence:Ethical and participant safety considerationsSite startup managementSite conduct managementRisk managementQuality managementSupply managementScientific concepts and clinical research designIssue escalation managementSkill areas:Negotiation and conflict resolutionCritical thinkingProblemsolvingDecision makingStrategic thinkingInterpersonal communication skills, presentation skills, flexibility, and ability to work well within a multidisciplinary team both autonomously and with a wide range of stakeholders.Why Join Us?At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people firstboth patients and our employees. By joining our team, you''ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.PurposeDriven Work: You''ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.We are an equalopportunity employer and encourage applications from all qualified candidates. #J-18808-Ljbffr