Senior Clinical Research Associate, Australia

Senior Clinical Research Associate, Australia Join Emerald Clinical to apply for the Senior Clinical Research Associate, Australia role at Emerald Clinical. About the Role The 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. Responsibilities Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial. Complete all monitoring activities per the Monitoring Plan and deliver 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 liaise with regulatory specialist colleagues regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages. Negotiate site budgets, coordinate 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 trial site personnel have a good understanding of the protocol, investigational product, and trial requirements. Manage trial sites utilising both on‑site and off‑site activities, including: Verification of quality, accuracy, completion, and timeliness of data. Ensuring complete and efficient resolution of data queries, audits, issues, and liaising with Data Management and/or Quality colleagues as needed. Adhering to the trial protocol and all applicable project‑related plans and other relevant project‑specific requirements. Adhering to ICH/GCP and other regulatory guidelines, including reporting of subject safety events, protocol violations, and liaising with safety colleagues. Ensuring targets, metrics, and quality are maintained per trial expectations. Identifying risks associated with trial design, privacy, confidentiality, and misconduct, and taking action to mitigate risk proactively and to escalade as appropriate. Collect, review, and approve essential documents from trial sites, ensure quality and compliance, and code documents for Trial Master File filing. Reconcile contents of in‑house 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. 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 Project Lead. About You Educated to degree level in pharmacy, medical, nursing, biological science, or other health‑related disciplines, or equivalent relevant experience. ≥5 years of 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. Displays high competence in ethical and participant safety considerations, site start‑up management, site conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management. Demonstrates high competence in negotiation and conflict resolution, critical thinking, problem‑solving, decision making, and strategic thinking. Demonstrates solid interpersonal communication and presentation skills, flexibility, and ability to work well within a multi‑disciplinary 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 first—both 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. Purpose‑Driven Work : Contribute to clinical trials that genuinely improve lives, focusing on renal, cardiometabolic, and oncology therapies. 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. We are an equal‑opportunity employer and encourage applications from all qualified candidates. #J-18808-Ljbffr