Parexel
Parexel
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, Central or Western US

Oversee investigator sites and clinical trial monitoring for Parexel across the Central or Western United States. Support patient safety, GCP compliance, recruitment, and study quality throughout the trial lifecycle.

विवरण

  • Oversee management, monitoring, and close-out of assigned clinical trial investigator sites.
  • Protect patient safety and ensure high-quality study conduct in line with applicable laws, GCP, and sponsor standards.
  • Manage investigator relationships and trial operations from site activation through database lock.
  • Act as the primary contact for assigned investigator sites.
  • Coordinate with Site Care Partners, study teams, vendors, and investigator sites.
  • Support site development through coaching, training, and protocol guidance.
  • Monitor sites onsite and remotely or electronically during initiation, routine follow-up, and closure.
  • Track adverse events and serious adverse events in collaboration with the Drug Safety Unit.
  • Submit TMF documents, site reports, follow-up letters, protocol deviations, recruitment updates, and study progress reports.
  • Identify and address site issues, developing corrective and preventive actions as needed.
  • Resolve data queries and carry out investigator site close-out activities.
  • Oversee investigational product receipt, handling, accountability, storage, and destruction.
  • Support database release and, where needed, conduct unblinded monitoring.
  • Maintain knowledge of products, protocols, and relevant therapy areas.
  • Support patient safety, eligibility assessments, and clinical guidance.
  • Lead quality-event remediation and audit CAPA activities.

आवश्यकताएँ

  • Strong knowledge of clinical trial methods, ICH/GCP, FDA requirements, and local regulations.
  • At least two years of relevant experience monitoring clinical research sites.
  • Fluency in English and the native language or languages of the country of employment.
  • Ability to travel 60–80% of the time.
  • Valid driver's license and passport.
  • Bachelor's degree in life sciences or an equivalent professional life sciences qualification, such as nursing, pharmacy, or medicine.

लाभ

  • Parexel is an equal opportunity employer.
  • Contribute to therapies that benefit patients and advance global health.

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