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Clinical Research Associate I

Abbott
Abbott
2+ years
Not Disclosed
Gurgaon, India
10 April 14, 2026
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 I – Gurgaon | Clinical Trials | Pharma Jobs

Company: Global Medical Device / Clinical Research Organization (Abbott Division)
Location: Gurgaon
Job Type: Full-Time
Work Mode: On-site / Hybrid
Experience: 2+ Years
Qualification: Life Sciences / Nursing / Bioengineering / Clinical Research


Job Overview

This role is a strong entry-to-mid level opportunity in clinical research, focusing on site management, regulatory documentation, and compliance within global clinical trials. As a Clinical Research Associate I (CRA I), you will support clinical site operations, ensure regulatory accuracy, and maintain high-quality clinical documentation aligned with global standards.

Working closely with US and EMEA teams, you will gain hands-on exposure to international clinical trial operations, regulatory compliance, and medical device research.


Key Responsibilities

Site Management & Regulatory Documentation

  • Collect and manage essential regulatory documents for clinical trial sites
  • Review documents for accuracy and completeness as per ICH-GCP and GDP guidelines
  • Maintain and update clinical trial systems (e.g., Study Organizer - SO)

Clinical Trial Compliance & Documentation

  • Support creation and maintenance of patient binders and regulatory binders
  • Ensure site-level compliance with clinical protocols and regulatory requirements
  • Assist in audit readiness and documentation tracking

Site Coordination & Issue Resolution

  • Collaborate with site teams, vendors, and internal stakeholders
  • Support follow-up and resolution of monitoring visit findings and audit observations
  • Escalate compliance issues to site or study management

Clinical Inventory & Logistics

  • Manage clinical trial inventory across sites and warehouses
  • Coordinate with global project teams and device accountability specialists
  • Handle import/export processes in compliance with SOPs and local regulations

Operational & System Support

  • Maintain internal clinical trial information and document management systems
  • Initiate translation of study documents (e.g., informed consent forms)
  • Contribute to process improvements and operational efficiency initiatives

Required Skills & Qualifications

Educational Requirements

  • Bachelor’s degree in:
    • Life Sciences
    • Nursing
    • Bioengineering
    • Pre-medicine or related field

Experience

  • Minimum 2 years of experience in Clinical Research / CRA / Site Management

Core Skills & Technical Expertise

  • Strong understanding of ICH-GCP and Good Documentation Practices (GDP)
  • Experience with clinical trial documentation and regulatory processes
  • Familiarity with TMF, regulatory binders, and clinical systems
  • Knowledge of clinical inventory management and logistics processes
  • Proficiency in MS Office (Excel, Word, PowerPoint)

Preferred Skills

  • Certification from ACRP or SoCRA
  • Exposure to global clinical trials or medical device studies

Soft Skills

  • Strong communication and stakeholder management skills
  • High attention to detail and organizational ability
  • Ability to manage multiple tasks and meet deadlines
  • Independent working capability with analytical thinking

Perks & Benefits

  • Exposure to global clinical trials and international teams (US/EMEA)
  • Career growth in clinical operations, monitoring, and regulatory roles
  • Opportunity to work in medical device and pharmaceutical research
  • Learning and certification support (ACRP, SoCRA)
  • Structured and compliance-driven work environment

About the Company

This organization is a global leader in healthcare and medical device innovation, supporting clinical research, regulatory compliance, and advanced therapies worldwide. With strong global operations, it plays a critical role in improving patient outcomes through cutting-edge clinical trials.


Salary / Compensation

💰 Not disclosed (Competitive industry-standard package)


Work Mode

📍 On-site / Hybrid – Gurgaon, India


Call to Action

If you’re aiming to grow in clinical trials, site management, and regulatory compliance, this is a high-value opportunity with global exposure.

👉 Apply now and advance your career in clinical research and pharma innovation.