Clinical Research Associate Ii.

Psi; Melbourne; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work arrangement (2 days flexi,

Onsite Gym access

Wellness leave (5 days)

Development and learning opportunities

Impactful industry work

Job summary

PSI is seeking a knowledgeable CRA II to manage the clinical aspects of global projects in Australia. You will work at the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research across multiple therapeutic indications.

You will build and maintain relationships with clinical sites and investigators, focusing on subjects’ rights, safety and well‑being and data quality.

Qualifications

• Degree in Life Sciences, Pharmacy, RN or equivalent.
• At least 2 years of independent on-site monitoring experience in Australia.
• Experience in Phase II/III monitoring visits.
• Experience in Inflammatory Bowel Disease, Oncology or Infectious Diseases is a plus.
• Full working proficiency in English.
• MS Word/Excel/PowerPoint proficiency.
• Ability to plan, multitask and travel.

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.

Skills

On-site monitoring

Teamwork

Communication

Problem-solving

Education

Bachelor-level degree in Life Sciences, Pharmacy, RN or equivalent

Tools

MS Word

Excel

PowerPoint

Job description

Job Description

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.

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

Qualifications

• 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

Additional Information

What you’ll get:

• Competitive salary
• We offer hybrid work arrangement - 2 days flexi and 3 days in office
• Access to a wide range of employee benefits such as onsite Gym access
• Additional 5 days of wellness leave
• Development and learning opportunities
• Chance to make a real impact in a meaningful industry

About Us

PSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 3000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.

How are we different?

PSI is privately owned by the very people who founded the company 30 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.

Being a Part of the Team

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.