Job Description
Company 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.
Job Description
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
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 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!
Additional Information
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.
