Senior Clinical Research Associate – Core Team

🔥 1 minute ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Act as Parexel’s direct contact with assigned clinical sites from initiation through closeout. • Assess study implementation integrity and adherence to protocol at sites, and resolve site issues. • Build relationships with investigators and site staff. • Facilitate access to study systems and ensure project-specific training compliance. • Evaluate site staffing, documentation, communication, recruitment, compliance, and performance; implement corrective actions and follow-up. • Participate in investigator and other meetings, audits, and regulatory inspections. • Collect, review, and approve updated site and regulatory documentation. • Perform qualification, initiation, monitoring, facilities assessment, and other on-site visits; conduct remote contacts as needed. • Generate visit/contact reports. • Assess and manage study supplies, accountability, destruction/return status, site payments, CRF entry, queries, and SAEs. • Conduct study-specific site training when applicable. • Recognize and communicate study non-compliance, delays, and issues requiring immediate action, with resolution strategies. • Complete project goals and update clinical trial management systems, including CTMS, EDC, IVRS, SIS, and TMF documentation. • Ensure assigned sites are audit- and inspection-ready and maintain ICH-GCP and regulatory compliance. • Work with project team members to plan efficiently, meet goals, and support deliverables. • Delegate and guide administrative tasks where appropriate and provide performance feedback. • Maintain high-quality, timely, and efficient work; keep the manager informed of progress and issues. • Develop subject-matter expertise and work independently with limited oversight. • Complete timesheets, expenses, metrics, and other assigned tasks.

🎯 Requirements

• Open to consider experienced CRAs based in Melbourne, Sydney, Brisbane, or Adelaide. • At least 4+ years of CRA experience from AUS or NZ with oncology trial experience is required. • Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology. • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience. • Sound problem solving skills. • Able to take initiative and work independently, and to proactively seek guidance when necessary. • Advanced presentation skills. • Client focused approach to work. • Ability to interact professionally within a client organization. • Flexible attitude with respect to work assignments and new learning. • Ability to prioritize multiple tasks and achieve project timelines, utilizing strong analytical skills to make decisions autonomously. • Willingness to work in a matrix environment and value teamwork. • Strong computer skills, including CTMS, EDMS, MS Excel, and MS Word. • Strong interpersonal, verbal, and written communication skills. • Effective time management and ability to meet study needs, team objectives, and department goals. • Developing ability to work across cultures. • Ability to work successfully in a virtual team environment. • Consulting skills and great attention to detail. • Able to accommodate extensive travel time requirements. • Holds a driver’s license where required.

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