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Clinical Research Associate

1-5 years
Not Disclosed
10 Sept. 22, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Clinical Research Associate (CRA)

Company: Sun Pharma Laboratories Ltd
Location: Chennai, India
Date Posted: Sep 17, 2025
Employment Type: Full-time


Role Overview

The Clinical Research Associate (CRA) will be responsible for managing clinical trial sites, ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. The role involves site management, monitoring, data oversight, and coordination with internal and external stakeholders throughout the clinical trial lifecycle.


Key Responsibilities

  • Perform site feasibility assessments, identify potential investigators, negotiate study budgets, finalize investigators and sites, and execute CDA and study-related contracts.

  • Prepare and submit study documents for Ethics Committee (EC) approval across study centers.

  • Oversee and document investigational product (IP) dispensing, inventory management, and reconciliation.

  • Ensure timely site initiation, monitoring, and close-out activities, generating respective reports.

  • Conduct training for investigators and site personnel on study protocol, procedures, and GCP principles.

  • Ensure timely participant recruitment, efficient data entry, source data verification, and query resolution.

  • Ensure timely reporting of SAEs, SUSARs, and compliance with Sun Pharma PV policies.

  • Identify, analyze, and implement CAPA for sites not meeting expectations.

  • Coordinate with in-house teams or CRO partners for data management, statistical analysis, and database lock (DBL).


Qualifications & Experience

  • Education: Bachelor’s or Master’s degree in Biology, Chemistry, Nursing, Pharmacy, Public Health, or Post-graduate Diploma in Clinical Research

  • Experience: 1–5 years in Clinical Research or related field

  • Knowledge of GCP, clinical trial protocols, and regulatory compliance


Skills & Competencies

  • Strong site management and monitoring skills

  • Excellent communication and coordination abilities

  • Ability to analyze site performance and implement corrective actions

  • Familiarity with clinical trial documentation, data management, and statistical reporting