Clinical Research Associate – Clinical Trials
Location: Hyderabad, India
Employment Type: Full-Time
Business Unit: Clinical Research
Company: Sun Pharma Laboratories Ltd
Office Location: Sun House – Corporate Office
Experience Required: 1–5 Years
Posting Date: December 6, 2025
Job Overview
Sun Pharma Laboratories Ltd is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to support the execution and oversight of clinical trials in compliance with global regulatory and ethical standards. This role plays a critical part in ensuring the successful planning, monitoring, and closure of clinical studies while maintaining data integrity, patient safety, and regulatory compliance.
The position offers exposure to Phase III and Phase IV clinical trials, cross-functional collaboration, and opportunities for professional growth within a leading global pharmaceutical organization.
Key Responsibilities
Site Management & Study Execution
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Conduct site feasibility assessments, identify and finalize investigators and study sites.
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Negotiate study budgets with investigators and support execution of Confidentiality Disclosure Agreements (CDAs) and clinical trial contracts.
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Ensure timely site initiation, routine monitoring visits, and site close-out activities with accurate documentation and reporting.
Regulatory & Ethics Committee Coordination
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Prepare and submit clinical study documents for Ethics Committee (EC) approvals across multiple sites.
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Ensure compliance with applicable regulatory guidelines, GCP standards, and internal SOPs.
Clinical Trial Monitoring
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Oversee Investigational Product (IP) dispensing, inventory management, and reconciliation.
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Ensure protocol adherence, accurate data entry, source data verification (SDV), and timely query resolution.
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Train investigators and site staff on study protocols, procedures, and Good Clinical Practice (GCP) principles.
Safety & Risk Management
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Ensure timely reporting of SAEs and SUSARs in accordance with regulatory requirements and Sun Pharma’s pharmacovigilance policies.
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Identify site-level risks, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA) for underperforming sites.
Cross-Functional Collaboration
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Coordinate with internal teams and CRO partners for data management, statistical analysis, database lock (DBL), and clinical study reports.
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Work closely with cross-functional stakeholders to ensure timely study milestones and quality outcomes.
Required Qualifications
Education
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Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, Biology, Chemistry, Public Health, or a related healthcare discipline.
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Postgraduate Diploma in Clinical Research is an added advantage.
Experience
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Minimum 1 to 5 years of relevant experience in clinical research or clinical trial monitoring.
Key Skills & Competencies
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Strong working knowledge of ICH-GCP guidelines and global clinical trial regulations
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Hands-on experience with Phase III and Phase IV clinical trials
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Proven expertise in site management and monitoring activities
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Effective communication and stakeholder coordination skills
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Strong organizational skills with attention to detail and data accuracy
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Ability to work independently and collaboratively in a fast-paced environment
Why Join Sun Pharma
At Sun Pharma, employees are empowered to grow professionally while contributing to meaningful healthcare advancements. The organization fosters a collaborative culture focused on continuous improvement, accountability, and shared success. Joining Sun Pharma means being part of a global team committed to improving patient lives through science and innovation.
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Equal Opportunity & Disclaimer
Sun Pharma Laboratories Ltd is an equal opportunity employer. Employment decisions are based on merit, qualifications, and business needs, without discrimination.
This job description outlines the general nature of the role and is not intended to be an exhaustive list of responsibilities. Duties may evolve based on organizational and regulatory requirements.
