Clinical Research Associate II – FSP

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Ensure clinical trials are conducted according to the Study Monitoring Plan, applicable laws, GCP, and client standards • Manage clinical trial activities at assigned investigator sites from activation through database lock • Serve as primary contact for assigned investigator sites and escalate issues to the SCP as needed • Facilitate information flow among study team members, vendors, and investigator sites • Perform site development, coaching, and training; provide protocol training and address site questions • Attend investigator meetings and support enrollment, site activation, recruitment, and recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure • Monitor adverse events and serious adverse events; collaborate with Drug Safety and investigators to resolve reports • Submit required TMF documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply, study progress, and metrics updates • Identify and resolve site issues; develop corrective and preventive actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and undertake unblinded monitor responsibilities where appropriate • Maintain product, protocol, and therapy-area knowledge and support patient safety and eligibility • Drive Quality Event remediation and audit CAPA activities when applicable • Report to the Director of Clinical Site Operations or Director of Site Management and Monitoring • Partner with SCP, Country Study Operations Manager, and other study team members • Mentor/train Clinical Research Associates and Senior CRA I as assigned • Serve as subject matter expert on related initiatives/planning • Complete required training, timesheets, expense reports, and CV updates; comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• At least 3+ years of CRA experience from Australia/New Zealand • Minimum 3 years relevant experience in clinical research site monitoring • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Global clinical trial experience • Fluency in English and the native language(s) of the country of work • Significant travel (60–80%) within the area; some international and weekend travel may be required • Valid driver’s license and passport required • Knowledge of clinical research and development processes • Knowledge of global and local regulatory requirements • Understanding of monitoring, data acquisition and cleaning, reporting, and other operational elements • Knowledge of disease and technical areas related to clinical studies, investigational products, and development plans • Ability to support sponsor regulatory interactions and inspections • Knowledge of protocol design and feasibility assessment processes • Understanding of regional/country culture and medical practices affecting clinical trial delivery • Ability to work in a matrix team environment and influence, drive/lead, and work through others • Ability to evaluate, interpret, and present complex issues and data for risk management and mitigation • Effective verbal and written communication skills • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent