Senior Clinical Research Associate, Australia

Senior Clinical Research Associate, Australia Join to apply for the Senior Clinical Research Associate, Australia role at Emerald Clinical 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 oncology – areas 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‑ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritising people, we deliver better engagement, more accurate data and faster results – bringing therapies to patients in need. 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 (SOPs). Responsibilities Coordinate 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 time‑frame. 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 concerning 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 so they can fulfil their obligations accurately and on time. Manage trial sites using 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 escalates 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 in‑house TMF and site’s Investigator Site Files. Coordinate distribution, tracking, handling and destruction of investigational products and other trial supplies per site/trial requirements. Maintain trial information using the clinical trial management system and 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 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 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 organisation 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 and 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 skills, presentation skills, is flexible and can work well within a multi‑disciplinary team both autonomously and with a wide range of varying stakeholders. Why Join Us? 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. Referrals increase your chances of interviewing at Emerald Clinical by 2x. Location: Brisbane, Queensland, Australia Seniority level: Not Applicable Employment type: Other Job function: Research, Analyst and Information Technology #J-18808-Ljbffr