Clinical Research Associate (Clinical Trials)
Company: Sun Pharma Laboratories Ltd
Location: Hyderabad, India
Business Unit: Clinical Research
Job Type: Full-Time
Experience Required: 1–5 Years
Education: Bachelor’s or Master’s Degree in Life Sciences / Pharmacy / Nursing / Public Health or Post-Graduate Diploma in Clinical Research
About Sun Pharma
Sun Pharma is one of the leading pharmaceutical companies committed to improving global health through innovation, research, and quality medicines. The organization promotes a culture of continuous learning, collaboration, and professional growth, encouraging employees to take ownership of their careers while contributing to meaningful healthcare advancements.
Job Overview
Sun Pharma is seeking a motivated Clinical Research Associate (CRA) to support and manage clinical trial activities across multiple study sites. The role involves overseeing clinical trial operations, ensuring compliance with Good Clinical Practice (GCP), regulatory guidelines, and company policies while maintaining high standards of data quality and patient safety.
Key Responsibilities
Conduct site feasibility assessments and identify potential investigators for clinical studies
Negotiate study budgets with investigators and finalize investigator and site selection
Execute Confidential Disclosure Agreements (CDA) and other study-related contracts
Prepare and submit study documents to Ethics Committees (EC) for approval across study centers
Manage Investigational Product (IP) dispensing, inventory tracking, and reconciliation
Ensure timely site initiation, routine monitoring visits, and site close-out activities with proper documentation
Train investigators and site staff on study protocols, procedures, and Good Clinical Practice (GCP) guidelines
Monitor participant recruitment progress and ensure accurate and timely data entry and source data verification
Review and resolve data queries while maintaining high data integrity standards
Ensure prompt reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in accordance with regulatory and pharmacovigilance requirements
Identify study risks, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA) for underperforming sites
Coordinate with internal teams or CRO partners for data management, statistical analysis, statistical reports, and database lock (DBL)
Required Skills and Competencies
Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements in clinical trials
Understanding of Phase III and Phase IV clinical trial processes
Site management and clinical monitoring expertise
Ability to collaborate effectively with cross-functional teams and external stakeholders
Strong analytical, organizational, and documentation skills
Why Join Sun Pharma
Sun Pharma provides a dynamic and supportive work environment that encourages innovation, collaboration, and professional growth. Employees benefit from opportunities to develop expertise in clinical research while contributing to impactful healthcare solutions worldwide.
Disclaimer
The above job description outlines the general responsibilities and expectations for this role. It is not intended to represent a complete list of duties, responsibilities, or qualifications. The organization reserves the right to modify responsibilities or assign additional tasks based on business requirements and the employee’s experience and expertise.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
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Carlow |Republic of Ireland :
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Donegal |Meath :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
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Tallinn |Hà Nội :
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