Job Title: Research Associate – Clinical BA/BE Studies
Location: Pune, Maharashtra, India
Company: Lupin
Employment Type: Full-Time
About the Role:
Lupin is seeking a detail-oriented Research Associate with 3–5 years of experience in clinical bioavailability (BA) and bioequivalence (BE) studies. The ideal candidate will be responsible for monitoring outsourced and in-house BA/BE studies, ensuring compliance with regulatory guidelines and company protocols. This role offers the opportunity to coordinate with global CROs and manage clinical study documentation throughout all phases.
Key Responsibilities:
Monitor outsourced clinical BA/BE studies at external CROs in accordance with study protocols and applicable regulatory requirements.
Coordinate with external CRO representatives for technical discussions, study updates, and query resolution.
Review Trial Master Files (TMF), screening MSRs, informed consent documents (ICDs), periodic CRFs, dosing, sample collection, and processing during monitoring visits.
Plan, execute, and supervise in-house BA/BE studies as a Clinical Research Coordinator (CRC).
Coordinate all in-house study activities including protocol training, TMF compilation, study planning, progress tracking, and resolution of study queries.
Ensure accurate raw data documentation and maintain data integrity during all clinical study phases.
Required Experience & Skills:
3–5 years of relevant experience in clinical research, particularly in BA/BE study monitoring and coordination.
Strong understanding of regulatory guidelines and clinical trial protocols.
Proficiency in TMF management, CRF review, and clinical study documentation.
Excellent coordination and communication skills for working with internal teams and external CROs.
Education:
Master’s degree in Pharmacy (M.Pharm) or a related field.
Preferred Competencies:
Attention to detail and strong analytical skills.
Ability to manage multiple clinical studies simultaneously.
Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
Why Join Lupin:
Opportunity to work with a leading global pharmaceutical company.
Exposure to both outsourced and in-house clinical BA/BE studies.
Career growth in clinical research and regulatory affairs.
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