Clinical Research Associate II

PSI CRO

3d • Hybrid

About The Position

We are 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.

Requirements

• 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
• 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

Nice To Haves

• Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus

Responsibilities

• 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

Benefits

• Competitive salary
• Access to a wide range of employee benefits such as onsite Gym access
• Additional 5 days of wellness leave
• Development and learning opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree