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




n
Nursing certification, medical technology, or laboratory technology qualification accepted
n
Minimum 3 years of relevant clinical research experience may substitute for the education requirement
n
At least 3 years of clinical monitoring experience
n
Thorough knowledge of regulatory requirements, including basic understanding of requirements in other countries
n
Thorough understanding of the drug development process
n
Fluent in the local office language and English, written and verbal
n
Full understanding of Serious Adverse Event reporting, reports, narratives, and follow-up
n
Advanced site monitoring skills
n
Advanced study site management skills
n
Advanced registry administration skills
n
Ability to work with minimal supervision
n
Valuable planning and organization skills
n
Good computer skills and working knowledge of computer packages
n
Advanced verbal and written communication skills
n
Ability to train and supervise junior staff
n
Ability to resolve project-related problems and prioritize workload for self and team
n
Ability to work within a project team and effectively in a matrix environment
n
Valid driver's license
n
Ability to travel,



including *****% overnight travel
n
n
Core Competencies
n
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.
n
Highest-signal resume keywords
n
n
Clinical Monitoring Experience
n
Regulatory Requirements Knowledge
n
Serious Adverse Event Reporting
n
Advanced Site Management Skills
n
Clinical Research Experience
n
n
ATS Optimization Keywords
n
Hard Skills
n
n
Clinical Monitoring
n
Site Management
n
Registry Administration
n
Data Management Systems
n
Protocol Compliance
n
Quality Control
n
Feasibility Assessment
n
CRF Review
n
Project Coordination
n
Budget Negotiation
n
n
Soft Skills
n
n
Planning and Organization
n
Verbal and Written Communication
n
Problem Resolution
n
Team Collaboration
n
Supervision and Training
n
n
Certifications & Qualifications
n
n
Nursing Certification
n
Medical Technology Qualification
n
Laboratory Technology Qualification
n
n
Industry Keywords
n
n
Clinical Research
n
Drug Development Process
n
Informed Consent Procedures
n
Investigator Meetings
n
Ethics Committee Submissions
n
n
Tools & Technologies
n
n
Clinical Trial Management Systems
n
Data Management Software
n
Computer Packages
n
#J-*****-Ljbffr

📌 Senior Clinical Research Associate (Victoria)
🏢 Jobtailor
📍 Victoria