Clinical Research Associate (CRA II / CRA III)
Location: Melbourne, Victoria, Australia – Level 13, 440 Collins Street
Job ID: 3426
Schedule: Full-time
Posting Date: 22 September 2025
Company Overview
Novotech is a global full-service Clinical Contract Research Organization (CRO):
Headquartered in Sydney, Australia with 34 offices across Asia-Pacific, North America, and Europe.
Employs over 3,000 staff and partners with 5,000+ clinical sites.
Provides end-to-end clinical development services across all trial phases:
Feasibility assessments
Ethics and regulatory submissions
Data management & statistical analysis
Medical monitoring & safety solutions
Central lab services
Report writing to ICH requirements
Project & vendor management
Certified with ISO 27001 (Information Security) and ISO 9001 (Quality Management).
Role Overview
The Clinical Research Associate (CRA) ensures:
The rights and well-being of trial participants are protected.
Clinical trial data are accurate, complete, and verifiable from source documents.
Compliance with ICH GCP guidelines, local & global regulations, and Novotech/Client SOPs.
The CRA acts as the primary contact between Investigational Sites, Novotech, and Sponsors and serves as a site relationship manager.
Hybrid working arrangements and flexible hours offered.
Minimum Qualifications & Experience
Graduate in Clinical or Life Sciences or relevant allied professions.
CRA II: Minimum 6 months of independent CRA monitoring experience.
CRA III: Minimum 2+ years of independent CRA monitoring experience.
Must have full unrestricted working rights in Australia (no sponsorship available).
Strong time management, attention to detail, team collaboration, and computer literacy.
Key Responsibilities
Site & Stakeholder Management
Build strong relationships with Principal Investigators, study coordinators, pharmacists, and site staff.
Foster internal and external customer relationships for timely, efficient project delivery.
Collaborate with In-house CRA (IHCRA) and Regulatory Start-Up Associate (RSA) for site essential documents.
Support ethics and regulatory submission and approval processes as needed.
Work with Regulatory Start-Up (RSU) Team to understand local and international regulatory requirements for clinical trials.
Recruitment & Engagement
Ensure participant recruitment meets site targets.
Drive site recruitment and engagement initiatives.
Prepare and update site-specific recruitment plans.
Monitoring & Compliance
Conduct monitoring visits per ICH GCP, including:
Site Selection
Site Initiation
Site Monitoring
Site Close-Out
Unblinded pharmacy visits
Co-monitoring visits
Visits may be onsite or remote as per Clinical Monitoring Plan (CMP).
Team & Culture
Work in a diverse and supportive global organization.
Empowered teams with a shared commitment to success.
Foster a strategic mindset, proactive decision-making, and collaboration.
Ongoing support from senior stakeholders and leadership.
Equal Opportunity Statement
Novotech is an Equal Employment Opportunity Employer committed to diversity and inclusion. Employment decisions are based on merit, qualifications, and business requirements, without regard to race, religion, gender, age, sexual orientation, disability, or other protected characteristics.
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