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 (CRA II) – Parexel, Remote United States
Monitor oncology and specialty clinical trials remotely for Parexel as a Clinical Research Associate. Oversee sites, compliance, recruitment, data quality, and participant safety.
विवरण
- Manage clinical sites from identification through closeout
- Act as the primary contact for assigned clinical site teams
- Conduct qualification, site initiation, monitoring, and termination visits
- Complete visit and contact reports promptly
- Maintain site quality and delivery across the study lifecycle
- Resolve site questions and issues to support study execution
- Protect study integrity while building investigator and site staff relationships
- Assess trial performance and protect participant rights, safety, and well-being
- Create patient recruitment strategies with clinical sites to meet enrollment timelines
- Maintain compliance with SOPs, study protocols and amendments, Good Clinical Practice, and regulatory requirements
- Assess reported data quality and integrity, site performance, and investigational product accountability
- Track the completeness and quality of regulatory documentation
- Verify site documentation
- Perform onsite monitoring and support enrollment and study delivery
आवश्यकताएँ
- At least 18 months of direct onsite monitoring experience as a Clinical Research Associate
- Required experience monitoring oncology, ophthalmology, metabolic, hematology, or CAR-T clinical trials
- Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline
- Working knowledge of Good Clinical Practice, applicable regulations, and clinical trial processes
- Experience with Clinical Trial Management Systems, Electronic Document Management Systems, and Microsoft Office, including Excel and Word
- Strong site relationship management, problem-solving, communication, interpersonal, written, verbal, organizational, and detail-oriented skills
- Able to work independently with urgency and limited supervision
- Able to manage competing priorities, assess changing situations, apply study protocols, and meet project deadlines
- Able to collaborate within a matrixed team and communicate clearly with internal and external stakeholders
- Ethical, patient-centered approach
- Client-focused and adaptable approach to assignments, with a commitment to continuous learning
लाभ
- Health, vision, and dental insurance
- Tuition reimbursement
- Vacation, holiday, and sick time
- Flexible spending and health savings accounts
- Work-life balance
- 401(k) with company match
- Pet insurance
- Paid time off
- Life insurance
- Additional benefits provided under applicable plan terms
- Potential eligibility for additional incentives, bonuses, or other compensation programs