Senior Clinical Research Associate – Core Team

🔥 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

• Act as Parexel’s direct contact with assigned clinical sites from study 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 • Support site access to study systems and ensure compliance with project-specific training • Evaluate staff assignments and implement corrective actions and follow-up where needed • Address training, documentation, communication, and prior-visit issues • Identify and evaluate potential data quality and integrity issues and implement follow-up actions • Participate in investigator meetings, external and internal 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, and other on-site visits; conduct remote visits and contacts as needed • Generate visit and contact reports • Evaluate site compliance and performance and recommend site-specific actions • Assess and manage study supplies, accountability, and destruction or return status • Review and follow up on site payments, CRF data entry, queries, and SAEs • Conduct study-specific on-site training where applicable • Perform site facility assessments • Communicate study non-compliance, issues, delays, and changes with proposed resolution strategies • Ensure timely and accurate completion of project goals and update trial management systems • Update and review CTMS, EDC, IVRS, and SIS data and ensure timely, high-quality site data entry • Manage and submit relevant documents to the Trial Master File and distribute study documents to sites • Ensure assigned sites are audit- and inspection-ready • Monitor compliance with ICH-GCP and applicable regulations • Delegate and review administrative tasks and provide performance feedback to management • Collaborate with project team members to meet goals and support efficient project planning • Maintain high-quality, timely, and efficient delivery while keeping the manager informed • Develop subject-matter expertise and work with limited oversight • Complete timesheets, expenses, metrics, and other assigned tasks

🎯 Requirements

• At least 4+ years of CRA experience from Australia or New Zealand • Oncology trial experience • Site Management experience or equivalent experience in clinical research • Understanding of clinical trials methodology and terminology • Educated to degree level; biological science, pharmacy, or another health-related discipline preferred • Equivalent nursing qualification or other equivalent experience accepted • Strong problem-solving skills • Ability to take initiative, work independently, and seek guidance when necessary • Advanced presentation skills • Client-focused approach • Ability to interact professionally within a client organization • Flexibility regarding work assignments and new learning • Ability to prioritize multiple tasks and achieve project timelines • Strong analytical and autonomous decision-making skills • Willingness to work in a matrix environment and value teamwork • Strong computer skills, including CTMS, EDMS, Microsoft Excel, and Microsoft Word • Strong interpersonal, verbal, and written communication skills • Ability to assist others in meeting 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 • Ability to accommodate extensive travel requirements • Driver’s license where required • Working knowledge of ICH-GCP Guidelines, international and local regulations, Parexel SOPs, sponsor training requirements, and study-specific procedures

🏖️ Benefits

• Full-time employment • Remote work arrangement for Australia-North Ryde • Potential consideration for experienced CRAs based in Melbourne, Sydney, Brisbane, or Adelaide