
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.
🔥 3 minutes ago
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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.
• Act as Parexel’s direct contact with assigned clinical sites from initiation through closeout • Assess and ensure study implementation integrity and protocol adherence at clinical sites • Perform problem-solving to address and resolve site issues • Build relationships with investigators and site staff • Facilitate access to relevant study systems and ensure project-specific training compliance • Evaluate site staff assignments and implement corrective actions and follow-up • Address training, documentation, communication, and prior-visit issues • Identify and evaluate data quality and integrity issues and implement follow-up actions • Participate in investigator meetings, external/internal meetings, audits, and regulatory inspections • Collect, review, and approve updated site and regulatory documentation • Evaluate site recruitment plans and provide improvement strategies • Perform qualification, initiation, on-site, and remote visits/contacts • Generate visit/contact reports • Evaluate site compliance and performance and recommend site-specific actions • Manage test article/study supplies, accountability, and destruction/return status • Review and follow up site payment status, CRF data entry, queries, and SAEs • Conduct study-specific on-site training when applicable • Perform site facilities assessments • Communicate study non-compliance, issues, delays, and changes with proposed resolution strategies • Complete project goals and update applicable trial management systems • Collaborate with project team members on planning, goals, and deliverables • Maintain CTMS and review site-level data in CTMS, EDC, IVRS, and SIS • Manage relevant documents in the Trial Master File and distribute study documents to sites • Ensure assigned sites are audit- and inspection-ready • Maintain compliance with ICH-GCP and applicable international and local regulations • Delegate and guide administrative tasks and provide performance feedback • Maintain high-quality work and collaborative relationships in a matrix environment • Keep manager informed of progress and issues • Develop subject-matter expertise • Complete timesheets, expenses, metrics, and other assigned tasks
• Open to consider Freelance CRAs with around or above 5 years of CRA experience, based in NSW, VIC, SA or QLD; preference is NSW and VIC • CRA experience from Australia is required • Oncology experience is desirable • 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 proactively seek guidance when necessary • Advanced presentation skills • Client-focused approach to work • Ability to interact professionally within a client organization • Flexible attitude toward work assignments and new learning • Ability to prioritize multiple tasks and achieve project timelines using strong analytical skills to make decisions autonomously • 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 • Ability to assist others to meet study/country deliverables while preserving patient safety • Effective time management • Developing ability to work across cultures • Ability to work successfully in a virtual team environment • Great attention to detail • Able to accommodate extensive travel requirements • Holds a driver's license where required
• Independent Contractor role for 6 months - 12 months (period will be determined later) • Full-time position
Apply Now🕒 4 days ago
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