We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D;, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market.

By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

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 Qualifications College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience

At least 2 years of independent in office 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.

📌 Clinical Research Associate II (Sydney)
🏢 Psi Cro
📍 Sydney