Senior Clinical Research Associate, Australia at Emerald Clinical Trials

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

22 Mar, 26

Salary

0.0

Posted On

22 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Site Management, Monitoring, Regulatory Compliance, Budget Negotiation, Data Management, Risk Management, Quality Management, Interpersonal Communication, Problem Solving, Decision Making, Strategic Thinking, Training, Mentoring, Oncology Experience, Ethical Considerations

Industry

Biotechnology Research

Description

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-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 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 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). 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 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 escalate 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 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 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 organization, or pharmaceutical environment. Must have at least 2-years on-site monitoring experience in the field of Oncology Displays high competence in the following technical areas: 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. 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 wide range of varying 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. 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.

Responsibilities

The Senior Clinical Research Associate is responsible for coordinating site management and monitoring tasks for clinical trials. This includes site selection, monitoring activities, regulatory compliance, and ensuring data quality.