Clinical Research Associate Job in Orbit Pharmaceuticals

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.

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

Application Link