Senior Clinical Research Associate

Psi CRO; Australia; Hybrid; AUD 100,000 - 150,000; Full time

Benefits offered by this job

Hybrid work arrangement

Gym access

Wellness leave

Development opportunities

Meaningful industry impact

Job summary

PSI CRO Australia is seeking a knowledgeable Senior CRA to manage the clinical aspects of global projects. You will oversee site monitoring, ensure timelines and data quality, and build strong relationships with investigators and sites across Australia. Travel readiness and on-site monitoring in Phase II/III will be required.

You will mentor Jr. CRAs, deliver training, and contribute to audits and regulatory support, while working in a hybrid arrangement with flexible in-office days.

Qualifications

• 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 Phase II and/or III monitoring visits.
• Availability to travel and work across sites.

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 and perform CRF review, source document verification and query resolution.
• Be responsible for site communication and management.
• Be involved in site identification process and contact for investigators, vendors and support services.
• Participate in feasibility research and prepare/present at Investigator’s Meetings.
• Support to Regulatory Affairs and maintenance of study-specific tracking systems.

Skills

Mentoring & supervision

Communication

Team collaboration

Adaptability

Travel readiness

Education

Life Sciences degree

Tools

MS Office

Job description

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 Senior CRA to manage the clinical aspects of full-service globalprojects 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.

• 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 inInflammatory 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.

What you’ll get:

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

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.