Orbit Pharmaceuticals, a leading player in the pharmaceutical industry, is hiring a Clinical Research Associate (CRA) in Ahmedabad, Gujarat. This role is ideal for professionals with a strong background in bioequivalence studies, pharmacokinetics, and clinical trial management. As a CRA, you will ensure compliance with GCP, GLP, and regulatory guidelines while contributing to the development of generic drug products.
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If you have 4+ years of experience in bioequivalence study design, on-site monitoring, and clinical trial execution, this is a high-impact opportunity to advance your career in clinical research.
Key Responsibilities
- Design and implement bioequivalence (BE) studies based on regulatory and scientific requirements.
- Develop and review study protocols, ensuring compliance with ICH/GCP guidelines.
- Conduct site selection, initiation, routine monitoring, and close-out visits both remotely and on-site.
- Perform source data verification (SDV) and ensure high-quality clinical data.
- Manage trial supplies, drug accountability, and study documentation.
- Collaborate with cross-functional teams: clinical operations, data management, and biostatistics.
- Conduct literature reviews on bioavailability and bioequivalence of drug products.
- Address regulatory queries and participate in audits/inspections.
- Maintain study timelines, budgets, and monitor risks with mitigation strategies.
Qualifications and Skills
- Educational Background: Master’s or PhD in Pharmacology, Pharmaceutical Sciences, or related field.
- Experience: Minimum 4 years in bioequivalence study design and on-site clinical monitoring.
- Technical Skills: Knowledge of pharmacokinetics, biostatistics, clinical trial methodologies, and pharmacokinetic analysis software.
- Regulatory Knowledge: Strong understanding of FDA, EMA, TGA, Health Canada, and ICH/GCP guidelines.
- Soft Skills: Excellent organizational, communication, problem-solving, and time-management skills.
- Mobility: Willingness to travel frequently for site visits.
Benefits
- Competitive salary range: ₹6,00,000 – ₹8,00,000 per annum.
- Exposure to bioequivalence and generic drug development projects.
- Professional growth in clinical research and regulatory affairs.
- Opportunity to work with cross-functional teams and global regulatory compliance.
How to Apply
SHARE YOUR RESUME HERE IF YOU HAVE EXPERIENCE : ashvini.nalawade@orbitpharma.uk
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