Clinical Research Associate II

We’re searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in Australia. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.
Location: Macquarie Park, NSW
You will:
Conduct and report all types of onsite monitoring visits
Be involved in study startup
Perform CRF review, source document verification and query resolution
Facilitate site budgets and contract negotiations
Monitor trial progress on the country level
Be responsible for site communication and management
Be a point of contact for in-house support services and vendors
Communicate with internal project teams regarding study progress
Participate in feasibility research
Support regulatory team in preparing documents for study submissions
College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
At least 2 years of independent on-site monitoring experience in Australia
Experience in all types of monitoring visits in Phase II and/or III
Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
Full working proficiency in English
PC skills to be able to work with MS Word, Excel and PowerPoint
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel
Candidate outside of NSW is encouraged to apply!

Employment type
Full-time

Work arrangement
Hybrid