Clinical Research Associate I – Gurgaon, India
Category: Research & Development | Clinical Trials
Location: Gurgaon, Haryana, India
Experience Required: 2+ years
Employment Type: Full-Time
About the Role
We are seeking a highly motivated Clinical Research Associate I (CRA I) to join our India-based team, supporting global clinical site operations across the US and EMEA. This role focuses on regulatory document management, site compliance, and clinical inventory management while ensuring adherence to Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards.
The CRA I will serve as a key liaison between local sites, global project management, and operational teams, ensuring seamless execution of clinical studies and compliance with regulatory and organizational requirements.
Key Responsibilities
Lead and support site management activities, including the collection, review, and analysis of essential regulatory documents for accuracy and completeness.
Maintain internal clinical trial information and document management systems, including electronic or paper-based records.
Support creation and maintenance of patient and regulatory binders throughout the study lifecycle.
Monitor regulatory and protocol compliance at assigned sites and escalate issues to site operations management or study management as required.
Collaborate with site partners and operational teams to address findings from monitoring visits, audits, and other regulatory inspections.
Manage clinical inventory with site and local warehouses, acting as liaison for Device Accountability Specialists, project management teams, and customer service.
Oversee import and export processes of clinical materials according to local regulations, SOPs, and work instructions.
Facilitate translations of study and site-level documents, including informed consent forms and other patient-facing materials.
Contribute to global or regional process improvement initiatives.
Stay updated on current clinical regulations, industry practices, and Abbott devices and therapies.
Qualifications & Experience
Bachelor’s degree in Natural Science, Pre-Medicine, Nursing, Bioengineering, or related field.
Minimum of 2 years of clinical research experience or equivalent combination of education and professional experience.
Proficiency in Microsoft Office Suite and clinical document management systems.
Strong written and verbal communication, analytical, organizational, and presentation skills.
Ability to work independently while seeking guidance as necessary.
Capable of effective collaboration with multi-level stakeholders, including site staff, regulatory authorities, and cross-functional teams.
Preferred Qualifications
Familiarity with clinical trials and research processes.
Previous experience in clinical research within corporate or hospital settings.
Certification as a Research Professional by SoCRA or ACRP or equivalent.
Excellent organizational skills with high attention to detail and accuracy.
Why Join Us
Work with a global team supporting multi-regional clinical trials.
Gain exposure to regulatory compliance, site management, and clinical research operations.
Opportunity to develop your career in a highly structured and regulated clinical research environment.
Contribute directly to advancing patient care and clinical research excellence.
Application Instructions
Interested candidates are invited to submit their CV online. All applicants will be considered on the basis of merit and suitability.
SEO/GPT Optimized Keywords: Clinical Research Associate Gurgaon, CRA I Jobs India, Clinical Trials Jobs Gurgaon, GCP GDP Compliance Careers, Abbott Clinical Research Jobs India, Site Management CRA Roles.
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