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PSI CRO AG एक वैश्विक कॉन्ट्रैक्ट रिसर्च संगठन है, जो क्लिनिकल परीक्षणों में सहयोग करता है और विशेष रूप से महत्वपूर्ण चरण 2 और चरण 3 अध्ययनों पर ध्यान केंद्रित करता है। इसका कार्य सूजन संबंधी आंत्र रोग, ऑन्कोलॉजी, हेमेटोलॉजी, संक्रामक रोगों, मल्टीपल स्क्लेरोसिस और दुर्लभ रोगों सहित विभिन्न उपचार क्षेत्रों में फैला हुआ है। कंपनी क्लिनिकल परीक्षणों की योजना बनाने और वित्तीय निगरानी के लिए एक स्वामित्व वाले प्लेटफ़ॉर्म का उपयोग करती है, जिससे टीमें अध्ययन की समयसीमाओं और बजट पर नज़र रख सकती हैं। PSI CRO AG की प्रोफ़ाइल स्वास्थ्य सेवा और परामर्श विशेषज्ञता को गुणवत्ता, अनुकूलता और विश्वसनीय परीक्षण संचालन पर ज़ोर देने के साथ जोड़ती है।
Senior Clinical Research Associate – Australia (Remote)
Lead clinical research activities for PSI CRO’s Australian trials, supporting site monitoring, stakeholder communication, participant safety, and data quality. This senior role covers complex studies, investigator training, audits, and regulatory documentation.
विवरण
- Oversee clinical activities for full-service global projects in Australia
- Serve as a primary point of contact for project stakeholders
- Keep clinical research projects aligned with timelines, targets, and quality standards
- Develop and sustain effective relationships with clinical sites and investigators
- Safeguard participant rights, safety, and well-being while maintaining data quality and compliance
- Train, mentor, and supervise junior CRAs on study-level responsibilities
- Plan, conduct, and document selection, initiation, routine, and closeout monitoring visits
- Provide training for investigators, site personnel, and project teams
- Contribute to complex clinical studies
- Review CRFs, verify source documents, and resolve queries
- Coordinate communication with clinical sites
- Support site identification and feasibility activities
- Create and present materials for Investigator Meetings
- Prepare for company audits, attend them, and address resulting findings
- Assist Regulatory Affairs with obtaining site regulatory documentation
- Keep study-specific automated tracking systems up to date
आवश्यकताएँ
- A college or university degree in Life Sciences, or an equivalent combination of education, training, and experience
- At least four years of independent on-site monitoring experience in Australia
- Experience conducting all types of monitoring visits in Phase II and/or Phase III studies
- Willingness and availability to travel
- Experience in inflammatory bowel disease, oncology, or infectious diseases is advantageous
- Proficiency with Microsoft Office applications
- Ability to plan effectively and work in a dynamic team environment
- Strong communication, collaboration, and problem-solving abilities
लाभ
- Competitive salary
- Hybrid work arrangement with two flexible days and three office days for Sydney-based employees
- Access to an on-site gym for Sydney-based employees
- Five additional wellness leave days
- Professional development and learning opportunities
- Opportunity to contribute to a meaningful industry
- Ongoing support from colleagues around the world
- Practical learning through on-the-job experiences
- Formal development programs
- A range of opportunities for continued career growth
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