Clinical Research Associate II

🔥 11 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Logo of PSI CRO AG

PSI CRO AG

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• 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 • Serve as a point of contact for in-house support services and vendors • Communicate with internal project teams regarding study progress • Participate in feasibility research • Support the regulatory team in preparing documents for study submissions • Manage the clinical aspects of full-service global projects in Australia • Ensure timelines, targets and clinical research standards • Build and maintain relationships with clinical sites and investigators • Focus on subjects’ rights, safety and well-being and quality of data compliance

🎯 Requirements

• 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 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

🏖️ Benefits

• Competitive salary • Hybrid work arrangement: 2 days flexi and 3 days in office • Onsite Gym access • Additional 5 days of wellness leave • Development and learning opportunities • Chance to make a real impact in a meaningful industry • Continuous support from global peers • On-the-job learning experiences • Formal development programs • Variety of opportunities to continue to grow throughout your career

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