Research Associate

Roles & Responsibilities
• Monitor outsourced BA/BE clinical studies conducted at external CROs in compliance with approved protocols and applicable regulatory guidelines
• Coordinate with CRO representatives for technical discussions, study updates, and issue resolution
• Review Trial Master File (TMF), screening reports, Medical Screening Reports (MSR), Informed Consent Documents (ICD), CRFs, dosing records, sample collection, and sample processing during monitoring visits
• Plan, execute, and supervise in-house BA/BE studies while acting as a Clinical Research Coordinator
• Coordinate end-to-end activities for in-house BA/BE studies including protocol training, TMF compilation, study planning, study updates, and query resolution
• Ensure accurate and complete raw data documentation throughout all phases of clinical studies
• Maintain compliance with GCP, SOPs, and internal quality standards

Qualification
• Master’s degree in Pharmacy (M.Pharm)

Experience
• 3–5 years of relevant experience in BA/BE studies or clinical research operations

Skills
• Strong knowledge of BA/BE study conduct and monitoring
• Experience working with CROs and in-house clinical teams
• TMF management and clinical documentation review
• Understanding of GCP and regulatory requirements
• Good coordination, communication, and organizational skills
• High attention to detail and data integrity

About the Organization
Lupin Biotech, a part of the Lupin Group, focuses on advancing clinical research and bioequivalence studies through high scientific and regulatory standards. The organization supports innovation and compliance across global pharmaceutical development programs.