Senior Clinical Research Associate

We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Australia. As a Senior CRA 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
Training, mentoring and supervising study level responsibilities for Jr. CRAs
Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
Delivering training of investigators, site staff and project teams
Work with complex studies
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Be involved in site identification process
Contact for clinical investigators, vendors and support services in regard to study progress
Participate in feasibility research
Preparation and delivering of presentations at Investigator’s Meetings
Preparation for and attendance at company’s audits; resolution of audit findings
Support to Regulatory Affairs in procurement of site regulatory documents
Maintenance of study-specific automated tracking systems
College/University degree in Life Sciences or an equivalent combination of education, training & experience
At least 4 years of independent on-site monitoring experience in Australia
Experience in all types of monitoring visits in Phase II and/or III
Availability to travel
Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
Proficiency in MS Office applications
Ability to plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
If you like to train and support others on their clinical research steps, and are also looking forward to future Lead Monitor roles, this position may just be the right one for you.
Candidates outside of Sydney are welcome to apply!

Employment type
Full-time

Work arrangement
Hybrid