Clinical Research Associate II at PSI CRO

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

On-site Monitoring, CRF Review, Source Document Verification, Query Resolution, Site Budget Negotiation, Contract Negotiation, Feasibility Research, Regulatory Documentation, Clinical Site Management, Stakeholder Communication, Multitasking, Problem-solving

Industry

Pharmaceutical Manufacturing

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 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 on-site monitoring experience in Australia 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 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 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.

Responsibilities

Manage clinical aspects of global projects in Australia, focusing on onsite monitoring visits and site management. Ensure subject safety, data compliance, and maintain strong relationships with clinical sites and investigators.