Senior Clinical Research Associate
PSI CRO
•Hybrid
About The Position
We are 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.
Requirements
- 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
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
Nice To Haves
- Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
- 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.
Responsibilities
- 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
Benefits
- Competitive salary
- Access to a wide range of employee benefits
- Additional 5 days of wellness leave
- Development and learning opportunities
- Chance to make a real impact in a meaningful industry
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
