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।
Senior Clinical Research Associate, FSP (Ohio, Remote)
Oversee investigator sites and clinical trial monitoring for Parexel’s clinical development programs. Support patient safety, GCP compliance, recruitment, and study quality.
विवरण
- Oversee management, monitoring, and close-out of assigned clinical trial sites.
- Protect patient safety and maintain study quality in line with applicable laws, GCP, and sponsor standards.
- Manage investigator site relationships and operations from activation through database lock.
- Act as the primary contact for assigned investigator sites.
- Coordinate information across study teams, vendors, and investigator sites.
- Coach and train site personnel, including on study protocols.
- Support enrollment and address site activation and recruitment challenges.
- Conduct onsite and remote or electronic monitoring for site initiation, routine visits, and site closure.
- Monitor adverse events and serious adverse events in coordination with the Drug Safety Unit.
- Submit trial documents, reports, tracking records, and study metrics on schedule.
- Identify and resolve site issues, and develop corrective and preventive actions.
- Resolve data queries and complete investigator site close-out activities.
- Oversee investigational product receipt, handling, storage, accounting, and destruction.
- Support database release and, when appropriate, perform unblinded monitoring duties.
- Keep product, protocol, and therapy-area knowledge current and guide investigators in support of patient safety.
- Lead Quality Event remediation and support CAPA activities for audit observations.
आवश्यकताएँ
- Bring extensive knowledge of clinical trial methods, ICH/GCP, FDA requirements, and local regulations.
- Have at least two years of relevant clinical research site monitoring experience.
- Be fluent in English and the native language or languages of the country of work.
- Be able to travel 60–80% of the time.
- Hold a valid driver’s license and passport.
- Have a bachelor’s degree in life sciences or an equivalent professional life sciences degree, such as nursing, pharmacy, or a medical qualification.
लाभ
- Equal opportunity employer.
- Travel reimbursement or other travel-related compensation is not specified.