Senior Clinical Research Associate – Contractor

• 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