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Clinical Research Associate (Clinical Trials)

Sun Pharma
Sun Pharma
1-5 years
Not Disclosed
Hyderabad, India
10 Feb. 27, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate (Clinical Trials)

Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Location: Hyderabad, India
Experience Required: 1–5 Years
Education: Bachelor’s or Master’s Degree in Life Sciences / Health Sciences (Biology, Chemistry, Nursing, Pharmacy, Public Health) and/or Postgraduate Diploma in Clinical Research
Job Type: Full-Time
Posted On: February 13, 2026

About the Company

Sun Pharma Laboratories Ltd is one of India’s leading pharmaceutical companies with a strong global presence. The organization is committed to advancing clinical research excellence, regulatory compliance, and patient-centric innovation across therapeutic areas.

Role Overview

The Clinical Research Associate (CRA) will be responsible for managing and monitoring Phase III and Phase IV clinical trials in compliance with ICH-GCP guidelines and applicable regulatory requirements. The role involves site management, regulatory documentation, safety reporting, risk mitigation, and coordination with cross-functional teams and CRO partners.

This position offers an opportunity to work in a structured clinical research environment with exposure to end-to-end trial lifecycle management.

Key Responsibilities

       Conduct site feasibility assessments and identify potential investigators

  • Negotiate study budgets and finalize investigators, clinical sites, and execute CDAs and study-related contracts

  • Prepare and submit study documentation for Ethics Committee (EC) approvals across study centers

  • Oversee Investigational Product (IP) dispensing, inventory management, and reconciliation processes

  • Ensure timely site initiation visits (SIV), routine monitoring visits (RMV), and close-out visits (COV), along with accurate monitoring reports

  • Train investigators and site personnel on study protocols, SOPs, and Good Clinical Practice (GCP) principles

  • Drive patient recruitment strategies and ensure accurate data entry, source data verification (SDV), and timely query resolution

  • Ensure prompt reporting of SAEs and SUSARs in compliance with regulatory standards and pharmacovigilance policies

  • Perform risk identification, root cause analysis, and implement CAPA for underperforming sites

  • Coordinate with internal teams and CRO partners for data management, statistical analysis, statistical reports, and database lock (DBL) activities

Required Skills and Competencies

  • Strong understanding of ICH-GCP guidelines and clinical trial regulations

  • Experience in Phase III and Phase IV clinical trials

  • Proficiency in site monitoring and clinical site management

  • Knowledge of pharmacovigilance reporting processes

  • Excellent documentation and compliance management skills

  • Strong communication and cross-functional collaboration abilities

  • Analytical mindset with risk management expertise

Why Join Sun Pharma

At Sun Pharma Laboratories Ltd, employees are encouraged to take ownership of their professional growth within a collaborative and compliance-driven clinical research ecosystem. The organization emphasizes continuous learning, ethical research practices, and impactful healthcare innovation.

Disclaimer

This job description outlines the general scope and level of responsibilities associated with the role. Responsibilities may be modified or expanded based on organizational requirements. The employer reserves the right to assign additional duties aligned with the candidate’s experience and business needs.

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