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2 days ago Be among the first 25 applicantsCompany DescriptionWe 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.Company DescriptionWe 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.PSIs 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 DescriptionWere 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, NSWYou will:Conduct and report all types of onsite monitoring visitsBe involved in study startupPerform CRF review, source document verification and query resolutionFacilitate site budgets and contract negotiationsMonitor trial progress on the country levelBe responsible for site communication and managementBe a point of contact for in-house support services and vendorsCommunicate with internal project teams regarding study progressParticipate in feasibility researchSupport regulatory team in preparing documents for study submissionsQualificationsCollege/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experienceAt least 2 years of independent on-site monitoring experience in AustraliaExperience in all types of monitoring visits in Phase II and/or IIIExperience in feasibility assessment and study set-up process is preferableExperience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plusFull working proficiency in EnglishPC skills to be able to work with MS Word, Excel and PowerPointAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility to travelAdditional InformationTake the next step in your career and join a company that genuinely focuses on its people.About UsPSI 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 theyre 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 TeamAs 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 OpportunitiesPSI 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.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at PSI CRO AG by 2xSign in to set job alerts for Clinical Research Associate roles.Expression of Interest - Clinical Trial Coordinator | Australia WideSydney, New South Wales, Australia 2 weeks agoClinical Trials Coordinator/Research NurseSydney, New South Wales, Australia 2 weeks agoDarlinghurst, New South Wales, Australia 2 weeks agoClinical Research Associate - CRA Australia (Level Depending on Experience)Sydney, New South Wales, Australia 1 month agoMacquarie Park, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 5 days agoSt Leonards, New South Wales, Australia 1 day agoInterstitial Lung Disease (ILD) Clinical Research Assistant (Health Manager Level 1) - RPA RespiratorySydney, New South Wales, Australia 2 days agoSt Leonards, New South Wales, Australia 1 week agoSydney, New South Wales, Australia 4 days agoNorth Sydney, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 2 weeks agoClinical Research Associate II: Bring your career to life at Fortrea!Research Co-ordinator: Infectious Diseases, SCH Randwick - REQ573107Millers Point, New South Wales, Australia 1 day agoGreater Sydney Area A$150.00-A$175.00 4 days agoBaulkham Hills, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 5 days agoSydney, New South Wales, Australia 2 weeks agoIntegrated Care Clinical Project CoordinatorHarris Park, New South Wales, Australia 1 day agoPharmacist Research Assistant PROACTIVE study (Penicillin allergy delabelling)St Leonards, New South Wales, Australia 4 days agoSydney, New South Wales, Australia 3 days agoSenior Clinical Research Associate (GC CRO)Sydney, New South Wales, Australia 3 weeks agoSenior Clinical Research Associate (GC CRO)Alexandria, New South Wales, Australia 1 month agoSenior Clinical Research Study Coordinator - Cancer Centre for Children - REQ579298Westmead, New South Wales, Australia 2 days agoPost-Doc Research Associate/Research Fellow - OphthalmologySydney, New South Wales, Australia 3 weeks agoWere unlocking community knowledge in a new way. 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