Senior Clinical Research Associate

🔥 22 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Manage the clinical aspects of full-service global projects in Australia • Work on the frontline of communication with project stakeholders • Ensure timelines, targets and standards of clinical research projects • Build and maintain relationships with clinical sites and investigators • Focus on subjects’ rights, safety and well-being and quality of data compliance • Train, mentor and supervise study-level responsibilities for Jr. CRAs • Prepare, conduct and report selection, initiation, routine and closeout monitoring visits • Deliver training to investigators, site staff and project teams • Work with complex studies • Perform CRF review, source document verification and query resolution • Manage site communication • Participate in site identification and feasibility research • Prepare and deliver presentations at Investigator’s Meetings • Prepare for and attend company audits and resolve audit findings • Support Regulatory Affairs in procuring site regulatory documents • Maintain study-specific automated tracking systems

🎯 Requirements

• 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

🏖️ Benefits

• Competitive salary • Hybrid work arrangement - 2 days flexi and 3 days in office (Sydney-based only) • 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 • Continuous support from global peers • On-the-job learning experiences • Formal development programs • Variety of opportunities to continue to grow throughout their career

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