Job Title

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 groupat Emerald Clinical. The Clinical Operations group is responsible for site management,monitoring tasks, and the operational support of clinical trials. The group allocates resourcesto projects as appropriate to assist with the implementation of project plans and to ensurecompliance with regulatory requirements and Standard Operating Procedures (SOPs).Responsibilities Coordinate the identification, feasibility assessment, and selection of investigators andsites to undertake the trial. Complete all monitoring activities per the Monitoring Plan along with completingmonitoring visit reports, accurately and within the predetermined timeframe. Prepare, plan, organise, and conduct site evaluation visits and report on these visits toassist with site selection. Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding thepreparation of regulatory packages, importation/exportation requirements, andupdates of Ethics Committee packages. Negotiate site budgets, coordinate for site contract execution, track invoicing, andensure 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 goodunderstanding of the protocol, investigational product, and requirements of the trial sothey 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, andliaise with Data Management and/or Quality colleagues, as needed. -Adhere to the trial protocol, all applicable project-related plans, as required bythe project training matrix, and other relevant project-specific requirements. -Adhere to ICH/GCP and other regulatory guidelines and requirements asrelevant to this trial including reporting of subject safety - adverse/seriousadverse events, protocol violations/deviations, and liaise with safety colleaguesas needed. -Ensure targets, metrics, and quality are maintained per trial expectations. -Identify risks associated with e.g., clinical trial design, privacy andconfidentiality, clinical trial misconduct, and take action to mitigate riskproactively and to escalate as appropriate. Collect, review, and approve essential documents from trial sites, to ensure quality andcompliance, and code documents for Trial Master File (TMF) filing. Reconcile contents of in-house TMF and site''s Investigator Site Files. Coordinate distribution, tracking, handling, and destruction of investigational productand other trial supplies per site/trial requirements. Maintain trial information using the clinical trial management system and any othertracking and reporting tools for the trial. Support strategies to boost recruitment efforts. Coordinate and perform translation verification of regional language, as required or asapplicable per region. Perform site close-out 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 ProjectLead.About YouEducated to degree level in pharmacy, medical, nursing, biological science, or otherhealth-related disciplines preferred or equivalent relevant experience5 years experience preferred, but 4 years may be considered based on relevantexperience in clinical trial monitoring and/or site management within an academic,contract research organization, or pharmaceutical environment.Must have at least 2-years on-site monitoring experience in the field of OncologyDisplays high competence in the following technical areas: ethical and participantsafety considerations, site start-up management, site conductmanagement, riskmanagement, quality management, supply management,scientific concepts andclinical research design, and issue escalation management.Demonstrate high competence in the following skill areas: negotiation and conflictresolution, critical thinking, problem-solving, decision making, and strategicthinking.Demonstrates solid interpersonal communication skills, presentation skills, is flexible,and can work well within a multi-disciplinary team both autonomously and with a widerange 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 equal-opportunity employer and encourage applications from all qualified candidates.