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ICON plc स्वास्थ्य सेवा और फार्मास्युटिकल उद्योगों को सेवाएँ प्रदान करने वाला एक वैश्विक कॉन्ट्रैक्ट रिसर्च संगठन है। इसका कार्य क्लिनिकल, परामर्श और वाणिज्यिक सेवाओं तक फैला है, जो शुरुआती अनुसंधान से लेकर विपणन-पश्चात गतिविधियों तक दवा विकास में सहायता करती हैं। कंपनी विकेंद्रीकृत क्लिनिकल परीक्षण, हृदय सुरक्षा, प्रारंभिक क्लिनिकल प्रयोगशालाएँ, मेडिकल इमेजिंग, नियामक इंटेलिजेंस और वास्तविक-विश्व साक्ष्य जैसी सेवाएँ प्रदान करती है। ICON plc हृदय रोग, ऑन्कोलॉजी, आंतरिक चिकित्सा, सेल और जीन थेरेपी तथा बायोसिमिलर जैसे क्षेत्रों में चिकित्सीय विशेषज्ञता भी उपलब्ध कराती है। डेटा विश्लेषण और रोगी-केंद्रित दृष्टिकोणों को मिलाकर कंपनी क्लिनिकल कार्यक्रमों को आगे बढ़ाने में मदद करती है।
Clinical Research Associate II (Remote, Texas)
Monitor sponsor-dedicated clinical trial sites for ICON Strategic Solutions while supporting regulatory compliance, patient safety, data quality, and site performance. This role serves as a key link between study sponsors and investigational sites.
विवरण
- Act as the main liaison between the sponsor and investigational sites
- Perform site selection, initiation, routine monitoring, and close-out visits
- Verify site adherence to ICH-GCP, standard operating procedures, and applicable regulations
- Keep clinical documentation current in CTMS and eTMF platforms
- Track site staff training and maintain compliance records
- Monitor participant safety and support prompt AE, SAE, and PQC reporting
- Contribute to participant recruitment and retention activities
- Manage drug accountability, including appropriate storage, return, or destruction
- Resolve data queries and promote accurate, timely data entry
- Record site progress and escalate emerging risks or issues
- Provide support for site budgets and payments when required
- Work closely with CTAs, LTMs, and CTMs
आवश्यकताएँ
- Bachelor’s degree in Life Sciences or an equivalent qualification, or eligibility as a qualified registered nurse
- Authorization to work in the United States without visa sponsorship
- At least two years of on-site monitoring experience in the pharmaceutical or CRO sector
- Monitoring experience spanning multiple therapeutic areas
- Working knowledge of ICH-GCP, local regulatory standards, and systems such as CTMS and eTMF
- Availability and ability to travel 60%–75% for monitoring visits across the Southeast region
- Strong communication, problem-solving, and collaboration skills
लाभ
- Base salary with performance-related incentives
- Medical, dental, and vision coverage through health and wellbeing programs where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programs and wellbeing resources
- Structured training and career development opportunities
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