Clinical Research Associate I/II – Core Team

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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 and ensure study implementation integrity and protocol adherence • Build relationships with investigators and site staff • Facilitate access to study systems and ensure compliance with project-specific training • Evaluate site staffing, documentation, communication, data quality, and data integrity; implement corrective and follow-up actions • Participate in investigator and other meetings, audits, and regulatory inspections • Collect, review, and approve updated or amended site and regulatory documentation • Evaluate site recruitment plans and provide improvement strategies • Perform qualification, initiation, monitoring, facility assessment, and close-out visits, including on-site and remote contacts • Generate visit and contact reports • Evaluate site compliance and performance and recommend site-specific actions • Manage test article and study supplies, including accountability and destruction or return • Review and follow up on site payments, CRF data entry, queries, and SAEs • Conduct study-specific site training when applicable • Recognize and communicate the impact of non-compliance, issues, delays, and changes on study timelines • Complete project goals and update clinical trial management systems • Maintain CTMS, EDC, IVRS, SIS, EDMS, and Trial Master File records with timely, high-quality data and documentation • Ensure assigned sites are audit- and inspection-ready and comply with ICH-GCP and applicable regulations • Delegate and guide administrative tasks and provide performance feedback • Maintain knowledge of Parexel SOPs, sponsor requirements, study procedures, and applicable regulations • Keep the manager informed of progress and issues, provide performance feedback, and develop subject-matter expertise • Complete timesheets, expenses, metrics, and other assigned tasks

🎯 Requirements

• CRA experience from Australia or New Zealand required, with at least 1 year of independent monitoring • Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology • Educated to degree level in biological science, pharmacy, or another health-related discipline, or equivalent nursing qualification or other equivalent experience • Sound problem-solving skills • Ability to take initiative, work independently, and proactively seek guidance when necessary • Advanced presentation skills • Client-focused approach and ability to interact professionally within a client organization • Flexible attitude toward work assignments and new learning • Ability to prioritize multiple tasks, meet project timelines, and make autonomous decisions using strong analytical skills • Willingness to work in a matrix environment and value teamwork • Strong computer skills, including CTMS, EDMS, Microsoft Excel, and Word • Strong interpersonal, verbal, and written communication skills • Effective time management and ability to meet study, team, and department goals • Developing ability to work across cultures • Ability to work successfully in a virtual team environment • Great attention to detail • Ability to accommodate extensive travel requirements • Driver’s license where required

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