IQVIA स्वास्थ्य सेवा डेटा विश्लेषण, उन्नत तकनीक और परामर्श सेवाओं को एकीकृत करके जीवन विज्ञान और स्वास्थ्य सेवा क्षेत्रों में संगठनों को जटिल चुनौतियों का समाधान करने में सहायता करती है। इसका कनेक्टेड इंटेलिजेंस प्लेटफ़ॉर्म डेटा और कृत्रिम बुद्धिमत्ता को एक साथ लाकर नैदानिक अनुसंधान, प्रौद्योगिकी विकास और नई उपचार पद्धतियों को आगे बढ़ाने में सहयोग करता है। कंपनी की टीमें विश्लेषण, परामर्श और स्वास्थ्य सेवा प्रौद्योगिकी के क्षेत्रों में काम करती हैं, जिससे अनुसंधान, डिजिटल नवाचार और रोगियों के बेहतर परिणामों से जुड़े अवसर मिलते हैं।
Clinical Research Associate - Hybrid in Melbourne
Support clinical trial sites and study data for IQVIA in Australia. The role covers recruitment, compliance, documentation, monitoring, and trial delivery.
विवरण
- Oversee site monitoring and management to ensure study conduct and data reporting meet protocols, regulations, guidelines, and sponsor requirements.
- Conduct site visits across selection, initiation, monitoring, and close-out stages.
- Implement, advance, and monitor subject recruitment plans.
- Deliver protocol and study training to assigned sites while maintaining regular site communication.
- Assess site practices for protocol and regulatory compliance, escalating quality concerns as needed.
- Monitor regulatory submissions, approvals, recruitment, enrollment, CRF completion, and the creation and resolution of data queries.
- Assist with study start-up activities when required.
- Maintain Trial Master File documentation and confirm that Investigator Site Files are properly maintained.
- Record site-management activities, monitoring findings, and action plans in visit reports and follow-up correspondence.
- Work with study team members to support project delivery.
- Help create site-specific subject recruitment plans when required.
- Oversee site finances and collect invoices in line with local requirements when required.
आवश्यकताएँ
- Bachelor’s degree in a scientific or healthcare discipline, or an equivalent combination of education, training, and experience.
- At least nine months of independent on-site monitoring experience.
- Working knowledge of clinical research regulations, including GCP and ICH guidelines.
- Working therapeutic-area and protocol knowledge gained through company training.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Ability to use a laptop, iPhone, and iPad when required.
- Strong organizational and problem-solving abilities.
- Effective time and financial management skills.
- Ability to build and maintain productive relationships with colleagues, managers, and clients.
लाभ
- Competitive salary plus car and health allowances.
- Flexible hybrid working arrangement.
- Career development opportunities across FSO and FSP models.
- Opportunity to work with experienced managers across clinical trials in multiple phases.