Lupin Limited is inviting applications for the position of Research Associate at its Pune (LBC) location. This opportunity is ideal for M.Pharm professionals with 3–5 years of experience in bioavailability (BA) and bioequivalence (BE) studies, clinical monitoring, and CRO coordination.
If you are looking to advance your career in clinical research, BA/BE study monitoring, and regulatory-compliant clinical operations, this role offers hands-on exposure to outsourced and in-house clinical study execution.
Job Overview
- Position: Research Associate
- Location: Pune, Maharashtra
- Company: Lupin Limited
- Experience: 3–5 Years
- Qualification: Master’s in Pharmacy (M.Pharm)
- Domain: BA/BE Clinical Research, CRO Monitoring
This Research Associate job in Pune focuses on monitoring outsourced clinical BA/BE studies at external CROs and coordinating in-house bioequivalence trials in compliance with regulatory guidelines.
Key Responsibilities
1. Monitoring of Outsourced BA/BE Studies
- Monitor outsourced clinical BA/BE studies at external CROs as per approved protocols.
- Ensure compliance with regulatory guidelines and GCP standards.
- Coordinate technical discussions and study updates with CRO representatives.
2. TMF & Clinical Documentation Review
- Review Trial Master File (TMF) documentation.
- Evaluate Screening MSR, ICDs, period CRFs, dosing records.
- Supervise sample collection, processing, and documentation.
- Verify raw data integrity during monitoring visits.
3. In-House BA/BE Study Coordination
- Plan, execute, and supervise in-house BA/BE studies as a Clinical Research Coordinator.
- Conduct protocol training for study teams.
- Manage TMF compilation and study planning.
- Prepare study updates and resolve study-related queries.
4. Regulatory & Compliance Oversight
- Ensure proper raw data documentation during all clinical study phases.
- Maintain inspection-readiness for audits and regulatory review.
This role demands strong expertise in clinical study monitoring, BA/BE operations, CRO management, and regulatory compliance.
Qualifications & Experience
- Master’s in Pharmacy (M.Pharm) – Mandatory
- 3–5 years of relevant experience in:
- Bioavailability & Bioequivalence (BA/BE) studies
- Clinical trial monitoring
- CRO coordination
- TMF management and documentation
- Strong knowledge of:
- ICH-GCP guidelines
- Regulatory requirements for clinical studies
- Clinical documentation and data integrity standards
Why Join Lupin?
Lupin Limited is one of India’s leading pharmaceutical companies with a strong global presence. Working as a Research Associate in BA/BE clinical studies provides:
- Exposure to global clinical development standards
- Experience in outsourced and in-house clinical operations
- Regulatory-focused clinical research environment
- Growth opportunities within clinical R&D
Salary & Benefits (Estimated)
- Salary Range: ₹6.5 – ₹9.5 LPA (based on experience and industry standards in Pune)
- Performance-driven work environment
- Learning exposure in regulatory-compliant BA/BE studies
- Career progression in clinical research domain