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Senior Clinical Research Associate, Australia3 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific 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 post-marketing.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 on-the-ground 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 Clinical Operations 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 along with completing 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 project-specific 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 they can fulfill their obligations to conduct the trial accurately and to deadlines.Manage trial sites utilising both on-site and off-site activities including:Verification of quality, accuracy, completion, and timeliness of data.Ensure complete and efficient resolution of data queries, audits, issues, and liaise with Data Management and/or Quality colleagues, as needed.Adhere to the trial protocol, all applicable project-related plans, as required by the project training matrix, and other relevant project-specific requirements.Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of subject safety - adverse/serious adverse events, protocol violations/deviations, and liaise 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 elevate 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 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 as 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, but 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 OncologyDisplays high competence in the following technical areas: ethical and participant safety considerations, site startup management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.Demonstrate high competence in the following skill areas: negotiation and conflict resolution, critical thinking, problem solving, decision making, and strategic thinking.Demonstrates solid interpersonal communication skills, presentation skills, is flexible, and can work well within a multi-disciplinary team both autonomously and with a wider range of varying 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.Here''s what makes us stand out:Purpose-Driven 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