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Premier Research, a global leader in clinical monitoring and site management, is seeking a Clinical Research Associate II to join their innovative team in India. This remote, full-time opportunity allows professionals to contribute to groundbreaking biotech, medtech, and specialty pharma projects, helping bring life-changing therapies, devices, and diagnostics to patients worldwide.
At Premier Research, your contributions matter, your ideas influence workflows, and your career growth is prioritized with flexible work-life balance opportunities.
Key Responsibilities
- Deliver quality, timely monitoring reports for sponsor approval as per the Clinical Monitoring Plan.
- Monitor clinical trials remotely, onsite, or via other approved methods, ensuring patient safety and data integrity in compliance with local regulations.
- Plan and prioritize day-to-day clinical site monitoring activities per study requirements.
- Conduct site qualification, study initiation, interim monitoring, and close-out visits as required.
- Maintain Trial Master File (TMF) or electronic TMF (eTMF) following ICH/GCP Section 8 essential document requirements.
- Review site documentation to ensure accuracy, completeness, and currency.
- Submit travel and expense reports according to company guidelines.
Required Qualifications
- Undergraduate degree or equivalent in clinical, science, or health-related field; or a licensed healthcare professional (e.g., registered nurse).
- Previous clinical research experience required.
- Completion of a CRA training program or equivalent.
- Strong understanding of clinical trial processes, GCP guidelines, and regulatory requirements.
Benefits
- Remote work flexibility with work-life balance.
- Exposure to biotech, medtech, and specialty pharma projects.
- Career development with global clinical monitoring experience.
- Competitive salary range: INR 7,00,000 – 10,00,000 per annum.
- Opportunity to make a direct impact on life-saving therapies.
How to Apply
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