Senior Clinical Research Associate (Early Phase Team), Melbourne at Emerald Clinical Trials

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

23 Jul, 26

Salary

0.0

Posted On

24 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Site Monitoring, Early Phase Trials, Regulatory Compliance, Site Selection, Budget Negotiation, Protocol Training, Risk Management, Quality Management, Trial Master File Management, Investigational Product Management, Stakeholder Management, Conflict Resolution, Critical Thinking, Problem Solving, Strategic Thinking

Industry

Biotechnology Research

Description

Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies. With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 800+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role We are seeking an experienced Senior Clinical Research Associate (Senior CRA) to join our Early Phase team based in Melbourne, Australia. This is a unique opportunity to play a foundational role in establishing Early Phase monitoring capability, contributing to operational frameworks, and supporting the growth of early phase clinical research activities in Australia. The successful candidate will lead monitoring activities across first‑in‑human, Phase I, Ib, and early Phase II studies, while also helping shape best practices, processes, and ways of working for the Early Phase team. 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. • 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 Must have at least 5 years on-site monitoring experience in Australia as a CRA. Experience with Oncology and Early Phase trials is highly regarded. 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 CRA will lead monitoring activities for early phase clinical trials, including site selection, initiation, and ongoing management. They are also responsible for ensuring regulatory compliance, managing site budgets, and mentoring junior staff members.