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Parexel एक वैश्विक क्लिनिकल रिसर्च संगठन है, जो नई दवाओं के विकास के दौरान बायोफार्मास्यूटिकल कंपनियों को सेवाएँ प्रदान करता है। इसका कार्य चरण I–IV क्लिनिकल परीक्षणों, पोर्टफोलियो और परीक्षण प्रबंधन, नियामक रणनीति, बाज़ार तक पहुँच तथा जीवनचक्र योजना तक फैला हुआ है। 21,000 से अधिक पेशेवरों के साथ, Parexel क्लिनिकल, नियामक और उपचार-विज्ञान संबंधी विशेषज्ञता को मरीजों की अंतर्दृष्टि और नवीन परीक्षण डिज़ाइनों के साथ जोड़ता है। कंपनी ऑन्कोलॉजी, न्यूरोसाइंस और दुर्लभ रोगों सहित विभिन्न क्षेत्रों में अनुसंधान का समर्थन करती है और क्लिनिकल विकास को अधिक कुशल तथा मरीज-केंद्रित बनाने पर ध्यान देती है।
Clinical Research Associate II – Remote, Virginia
Parexel is hiring a Clinical Research Associate II to monitor investigator sites and support clinical trial quality, patient safety, recruitment, compliance, and close-out activities across the United States.
विवरण
- Manage monitoring and close-out activities for assigned clinical trial investigator sites
- Maintain patient safety and study quality in compliance with applicable laws, GCP, and sponsor standards
- Oversee investigator site relationships and operations from activation through database lock
- Act as the primary contact for assigned investigator sites
- Coordinate information sharing among study teams, vendors, and investigator sites
- Coach and train site personnel while providing protocol support
- Assist with site activation, recruitment initiatives, and enrollment
- Perform onsite and remote electronic monitoring during initiation, routine visits, and site closure
- Track adverse events and serious adverse events in collaboration with the Drug Safety Unit
- Prepare TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, and study progress reports
- Identify site issues, resolve them, and develop corrective and preventive actions
- Resolve data queries and complete investigator site close-out activities
- Oversee investigational product receipt, handling, accountability, storage, and destruction
- Support database release and unblinded monitoring when appropriate
- Maintain current knowledge of products, protocols, and relevant therapy areas
- Support patient safety, eligibility assessments, and clinical guidance
- Lead Quality Event remediation and audit CAPA activities when applicable
आवश्यकताएँ
- At least two years of relevant experience in clinical research site monitoring
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and applicable local regulations
- Fluency in English and the native language or languages of the country of employment
- Willingness and ability to travel 60–80%
- Valid driver’s license and passport
- Bachelor’s degree in life sciences or an equivalent professional life-sciences qualification, such as nursing, pharmacy, or a medical degree
लाभ
- Equal opportunity employment
- Travel allowance is implied by the required travel; no explicit benefit is stated
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