Clinical Research Associate 2

🔥 1 hour ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Emerald Clinical

Emerald Clinical

501 - 1000 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Emerald Clinical is a leading global clinical research organization (CRO) founded in the Asia‑Pacific region that provides end‑to‑end clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and post‑marketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.

📋 Description

• Coordinate investigator and site identification, feasibility assessment, and selection • Complete monitoring activities according to the Monitoring Plan • Prepare monitoring visit reports accurately and within predetermined timeframes • Plan, organize, conduct, and report on site evaluation visits • Prepare and submit regulatory packages and manage importation/exportation requirements and Ethics Committee package updates • Negotiate site budgets and coordinate site contract execution • Track invoicing and ensure timely site payments • Conduct site initiation visits • Develop and maintain monitoring tools and project-specific documents • Motivate and train investigators and trial site personnel on protocols, investigational products, and trial requirements • Collect, review, approve, and code essential trial-site documents for Trial Master File filing • Reconcile in-house Trial Master File and Investigator Site File contents • Coordinate distribution, tracking, handling, and destruction of investigational products and trial supplies • Maintain trial information in the clinical trial management system and tracking/reporting tools • Support recruitment strategies

🎯 Requirements

• Tertiary qualifications in a related science or health care discipline • More than 2 years’ experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical environment is mandatory • Experience in renal and/or oncology clinical trials is a plus • Practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements • 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 • Competence in negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking • Solid interpersonal communication and presentation skills • Flexibility to work within a multidisciplinary team autonomously and with varied stakeholders • Ability to adapt to changing organizational priorities and ambiguous environments • Ability and willingness to travel

🏖️ Benefits

• Competitive compensation with a tailored salary and benefits package reflecting skills and experience • Hybrid or remote working arrangements, depending on location and role • Learning opportunities and access to a global network of scientific leaders • Employee wellbeing programs and initiatives supporting work-life balance, health, and team connection • Global engagement surveys • Recognition programs • Team-building events • Exposure to diverse international projects and clients

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