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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 offers a strong foundation in clinical trial operations with a focus on site management, regulatory documentation, and compliance. As a Clinical Research Associate I (CRA I), you will support global clinical studies by ensuring regulatory accuracy, maintaining trial documentation, and coordinating with cross-functional teams.

You will work closely with global clinical site operations teams (US/EMEA), making this an excellent opportunity to gain international exposure in clinical research and regulatory compliance.


Key Responsibilities

Site Management & Regulatory Support

  • Collect, review, and manage essential regulatory documents for clinical trial sites
  • Ensure compliance with ICH-GCP and Good Documentation Practice (GDP) standards
  • Maintain and update clinical trial documentation systems (e.g., Study Organizer - SO)

Clinical Trial Documentation & Compliance

  • Support creation and maintenance of patient binders and regulatory binders
  • Ensure completeness and accuracy of site-level documentation
  • Assist in regulatory submissions and compliance tracking

Site Coordination & Issue Resolution

  • Collaborate with site teams, vendors, and global stakeholders
  • Support resolution of audit findings and monitoring visit observations
  • Escalate compliance or documentation issues to management

Clinical Inventory & Logistics Management

  • Manage clinical trial inventory in coordination with sites and warehouses
  • Handle import/export processes as per regulatory requirements and SOPs
  • Liaise with global project teams and device accountability specialists

Operational Support & Continuous Improvement

  • Maintain internal systems and clinical trial data records
  • Initiate document translations (e.g., informed consent forms) when required
  • 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 knowledge of ICH-GCP and GDP guidelines
  • Experience with clinical trial documentation and regulatory processes
  • Familiarity with TMF, regulatory binders, and study documentation systems
  • Understanding of clinical inventory management and logistics
  • Proficiency in MS Office (Excel, Word, PowerPoint)

Preferred Skills

  • Certification from ACRP or SoCRA
  • Experience in global clinical trials or medical device studies

Soft Skills

  • Strong communication and stakeholder coordination skills
  • High attention to detail and organizational ability
  • Ability to manage multiple tasks and meet deadlines
  • Independent working capability with problem-solving mindset

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 pharma research domains
  • Learning and certification support in clinical research
  • Structured and compliance-driven work environment

About the Company

This organization is a global leader in healthcare and medical devices, supporting innovative clinical research and regulatory excellence. With a strong presence in global clinical operations, it plays a vital role in advancing medical technologies and improving patient outcomes worldwide.


Salary / Compensation

💰 Not disclosed (Competitive industry-standard package)


Work Mode

📍 On-site / Hybrid – Gurgaon, India


Call to Action

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

👉 Apply now and accelerate your career in clinical trials and pharmaceutical research.