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About the Role

The Clinical Research Associate (CRA) serves as the primary point of contact for assigned study sites, ensuring clinical trials are conducted in compliance with regulatory requirements, SOPs, and ICH GCP guidelines. This role involves managing site activities, monitoring study progress, and supporting project teams to advance treatments for chronically and critically ill patients.

Responsibilities

• Serve as the main CTI contact for assigned study sites
• Conduct site visits including PSV, SIV, IMV, and COV
• Oversee study start-up activities and site selection
• Collect, review, and track essential regulatory documents
• Participate in investigator, client, and project team meetings
• Create and implement subject enrollment strategies
• Ensure proper storage and accountability of Investigational Product
• Perform site management and provide status updates to the Clinical Project Manager
• Conduct remote monitoring activities
• Utilize systems to track subject status, CRF retrieval, and source document review
• Assist in the development of CRFs and study-related documents
• Translate and review Patient Information sheets, Informed Consent, and protocol synopses
• Support Regulatory Affairs with submission documentation for Ethics Committees and Regulatory Authorities
• Provide regular updates to sponsors and clients
• Support contract negotiations and site payment tracking
• Manage ISF and TMF documentation
• Identify site issues and implement corrective and preventive actions
• Liaise with Clinical Data Management for data cleaning
• Mentor and train other CRAs
• Function as Lead CRA for assigned projects
• Identify and propose process improvements
• Provide therapeutic area expertise

Requirements

• At least 3 years of clinical trial monitoring experience or equivalent
• Fluent in English
• Must be fully eligible to work in Australia
• Previous experience in clinical research within a hospital, pharmaceutical company, or as a CRA

Skills

• Clinical trial monitoring
• Regulatory compliance
• ICH GCP knowledge
• Site management
• Clinical data management
• Therapeutic area expertise
• Mentorship and training

Location

• Sydney, Australia

Work Type

• Hybrid

Experience Level

• At least 3 years of experience

Education Level

• Bachelor's Degree or higher in an allied health field
• RN with Associate's Degree
• 3-year Nursing Diploma with at least 2 years clinical nursing experience

Benefits

• Structured mentoring program
• Leadership courses
• Tuition reimbursement
• Generous health benefits
• Vacation packages
• Hybrid work opportunities
• Paid parental leave
• CTI Cares program

About the Company

• Global, privately held, full-service clinical contract research organization (CRO)
• Focused on the advancement of treatments for chronically and critically ill patient populations
• Headquartered in the Greater Cincinnati, OH region
• Collaborates with pharmaceutical, biotechnology, and medical device firms