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Clinical Research Associate - Cra

Sun Pharma
Sun Pharma
Fresher years
3-5 LPA
Mumbai, India
7 April 27, 2026
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc., Lifesciences graduate 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: Mumbai, India (Sun House – Corporate Office)

Department: Medical Affairs & Clinical Research

Job Type: Full-Time

Experience Required: 3–5 Years (suitable for freshers)

Date Posted: April 14, 2026


About the Company

Sun Pharma Laboratories Ltd is one of the world’s leading pharmaceutical companies, known for its innovation-driven approach and strong global presence. The organization fosters a growth-oriented culture where professionals are encouraged to take ownership, collaborate effectively, and continuously evolve within the healthcare ecosystem.


Job Overview

We are seeking an experienced Clinical Research Associate (CRA) to manage and monitor clinical trials across multiple sites. The role involves working closely with Contract Research Organizations (CROs), investigators, regulatory bodies, and internal stakeholders to ensure high-quality clinical trial execution in compliance with global regulatory standards.


Key Responsibilities

CRO Managed Studies

  • Manage CRO partners to ensure efficient execution of interventional, non-interventional, and epidemiological studies

  • Identify and evaluate investigators and clinical trial sites in collaboration with CROs and internal teams

  • Support preparation and review of regulatory submissions including Ethics Committee (EC) and DCGI documentation

  • Ensure vendor management in accordance with company policies and compliance standards

  • Coordinate clinical trial agreements and financial contracts with investigators and sites

  • Liaise with cross-functional teams including Medical Affairs, Regulatory, and Quality Assurance

  • Oversee investigational product planning, procurement, and distribution

  • Ensure timely reporting of SAEs and SUSARs to regulatory authorities and stakeholders

  • Facilitate CRO training on pharmacovigilance practices

In-House Managed Studies

  • Conduct site feasibility assessments and investigator identification

  • Manage study budgets, contracts, and Confidential Disclosure Agreements (CDAs)

  • Organize investigator meetings and site initiation activities

  • Prepare and submit study documents for Ethics Committee approvals

  • Coordinate investigational product supply and inventory management

  • Perform site selection, initiation, monitoring, and close-out visits

  • Ensure compliance with protocol, GCP, and regulatory requirements

  • Conduct source data verification, CRF review, and informed consent checks

  • Monitor adverse events and ensure accurate safety reporting

  • Drive patient recruitment and ensure efficient data management

  • Prepare monitoring visit reports and coordinate project meetings

  • Identify risks and implement CAPA strategies for underperforming sites

  • Collaborate with data management and biostatistics teams for analysis

  • Lead query resolution and maintain trial budget accountability


Educational Qualifications

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biology, or related field

  • Postgraduate Diploma in Clinical Research is preferred


Required Skills and Experience

  • 3–5 years of experience in Clinical Research, Clinical Operations, or CRA roles within Pharma, CRO, or Biotech organizations

  • Experience in managing multi-site clinical trials across therapeutic areas

  • Strong knowledge of ICH-GCP guidelines, New Drugs and Clinical Trial Rules (2019), ICMR guidelines, and Drugs & Cosmetics Act

  • Experience in audit and inspection readiness

  • Familiarity with risk-based monitoring and remote monitoring approaches

  • Strong analytical and research methodology skills

  • Ability to work in matrix environments with cross-functional collaboration

  • Proven performance track record in clinical research delivery


Core Competencies

  • Integrity-driven decision making

  • Strong clinical research and operational expertise

  • Strategic thinking with attention to detail

  • Effective collaboration and stakeholder management

  • High accountability and performance-driven mindset

  • Excellent communication and interpersonal skills

  • Adaptability and problem-solving ability


Work Environment and Travel Requirements

  • Primarily office-based role in Mumbai

  • Requires travel approximately 8–10 days per month for site visits


Important Note for Applicants

This position requires prior hands-on experience in clinical trial monitoring and operations. Freshers are advised to explore entry-level roles such as Clinical Trial Assistant (CTA), Clinical Data Coordinator, or Pharmacovigilance Associate before applying for CRA-level roles.


Disclaimer

The job description outlines the general responsibilities and expectations for this role. The organization reserves the right to modify duties based on business needs and operational requirements.