Monitor and manage clinical study sites, including routine monitoring, closeout, pre-study, and initiation visits
Maintain study files and liaise with vendors
Ensure study staff receive materials and instructions to safely enroll patients
Verify informed consent procedures and protocol compliance
Review source documents and monitor data for missing or implausible information
Ensure site-level audit readiness and prepare accurate, timely trip reports
Manage small projects and serve as lead monitor for assigned protocols or projects
Review project progress and initiate actions to achieve objectives
Organize and present at Investigator Meetings
Participate in protocol, Case Report Form, and clinical trial report development
Coordinate clinical trial supplies and vendors
Manage registry activities and undertake feasibility work
Conduct, report, and follow up on Quality Control visits
Recruit investigators and support ethics committee and regulatory submissions
Negotiate study budgets and assist with agreements
Track and follow up on Serious Adverse Event reporting
Perform CRF review, query generation, and resolution in data management systems
Train, mentor, and develop new employees
Coordinate designated clinical projects as a Local Project Coordinator and act as local client contact when assigned
Perform other duties assigned by management
Requirements
University or college degree in life science preferred, or certification in a related allied health profession from an appropriately accredited institution
Nursing certification, medical technology, or laboratory technology qualification accepted
Minimum 3 years of relevant clinical research experience may substitute for the education requirement
At least 3 years of clinical monitoring experience
Thorough knowledge of regulatory requirements, including basic understanding of requirements in other countries
Thorough understanding of the drug development process
Fluent in the local office language and English,



written and verbal
Full understanding of Serious Adverse Event reporting, reports, narratives, and follow-up
Advanced site monitoring skills
Advanced study site management skills
Advanced registry administration skills
Ability to work with minimal supervision
Positive planning and organization skills
Good computer skills and working knowledge of computer packages
Advanced verbal and written communication skills
Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritize workload for self and team
Ability to work within a project team and effectively in a matrix environment
Valid driver's license
Ability to travel, including *****% overnight travel
Core Competencies
Demonstrates advanced clinical monitoring and site management skills, with a thorough understanding of regulatory requirements and the drug development process.
Proficient in Serious Adverse Event reporting and capable of training and supervising junior staff while managing clinical study sites effectively.
Highest-signal resume keywords
Clinical Monitoring Experience
Regulatory Requirements Knowledge
Serious Adverse Event Reporting
Advanced Site Management Skills
Clinical Research Experience
ATS Optimization Keywords
Hard Skills
Clinical Monitoring
Site Management
Registry Administration
Data Management Systems
Protocol Compliance
Quality Control
Feasibility Assessment
CRF Review
Project Coordination
Budget Negotiation
Soft Skills
Planning and Organization
Verbal and Written Communication
Problem Resolution
Team Collaboration
Supervision and Training
Certifications & Qualifications
Nursing Certification
Medical Technology Qualification
Laboratory Technology Qualification
Industry Keywords
Clinical Research
Drug Development Process
Informed Consent Procedures
Investigator Meetings
Ethics Committee Submissions
Tools & Technologies
Clinical Trial Management Systems
Data Management Software
Computer Packages
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📌 Senior Clinical Research Associate (Melbourne)
🏢 Jobtailor
📍 Melbourne