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
As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
Location: Macquarie Park, NSW
You will:
* Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
* Act as the main line of communication between project team, Sponsor and the site
* Ensure that subject recruitment targets and project timelines are met at site level
* Perform CRF review, source document verification, drug accountability, and query resolution
* Facilitate the flow of site documents, assist in maintaining study-specific and corporate tracking systems
* Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages
* Conduct project-specific training of Investigators, prepare Investigator newsletters
* Participate in study site audits and client onsite visits, as required
* Monitor project timelines and patient enrollment, implements respective corrective and preventive measures
* Support junior Monitors in the query resolution process, including Central Monitoring observation
* Coordinate safety information flow and protocol/process deviation reporting
* Perform clinical supplies management with vendors
* Support site contracting and payments
* May lead project team calls on a country level
Qualifications
* College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
* At least 5 years of independent on-site monitoring experience or an equivalent experience
* Experience in all types of monitoring visits in Phase II and/or III
* Experience in feasibility assessment and study set-up process is preferable
* Experience in Oncology or Hematology therapeutic indications is a plus (preferable)
* 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
* 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.