Clinical Research Associate Job at Abbott | Bioengineering | Apply Now
Abbott is looking for a Clinical Research Associate I (Site-ICRA I) based in Gurgaon to serve as a pivotal link between Indian site operations and the US/EMEA Clinical Site Operations teams. This Clinical Research Associate Job focuses on maintaining the high standards of Good Clinical Practice (GCP) and Good Documentation Practice (GDP) throughout the clinical trial lifecycle. As an essential part of the Research & Development division, you will manage regulatory documentation, patient binders, and device accountability, ensuring that Abbott’s life-changing medical technologies are tested with absolute precision and compliance. If you have a background in Bioengineering or natural sciences and a passion for clinical data integrity, an Abbott Career offers a structured path into global clinical site management.
- Job Position: Clinical Research Associate I
- Location: Gurgaon
- Category: Research & Development
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. With approximately 115,000 employees serving people in more than 160 countries, Abbott is recognized for its commitment to innovation and its mission to create the future of healthcare. Joining Abbott means being part of a team that values diversity, excellence, and the relentless pursuit of better health outcomes for communities worldwide.
Key Responsibilities
In this role, you will provide critical support to clinical sites, ensuring they remain compliant and audit-ready at all times.
- Regulatory Documentation: Leading the collection, review, and analysis of essential site regulatory documents for accuracy and completeness per GCP and GDP standards.
- System Maintenance: Updating and maintaining internal clinical trial information and document management systems (such as Study Organizer) in both paper and electronic formats.
- Trial Binder Management: Supporting the creation and maintenance of patient and regulatory binders throughout the entire study lifecycle to ensure protocol compliance.
- Audit & Monitoring Support: Collaborating with site partners to resolve findings from monitoring visits and audits, serving as a liaison for Business Unit deliverables.
- Clinical Inventory & Logistics: Managing clinical device inventory between the site and local warehouse, including handling import/export processes per local regulations and Abbott SOPs.
- Translation Coordination: Initiating the translation of study-level and site-level documents, including Patient Informed Consent forms and other critical trial assets.
Qualification & Requirements: Bioengineering Job
Abbott is seeking a detail-oriented professional with strong analytical skills and a foundation in the sciences.
- Education: A Bachelor’s degree is required, preferably with an academic focus in Bioengineering.
- Work Experience: Minimum of two years of experience in a related scientific or clinical research setting.
- Professional Certification (Preferred): Certification as a Research Professional by SoCRA or ACRP is highly valued.
- Technical Proficiency: Must be proficient in the Microsoft Office Suite and capable of interpreting basic clinical data.
- Communication Skills: Strong written and verbal communication skills are essential for interacting with contractors, vendors, and global project management teams.
- Operational Excellence: Proven ability to work independently, prioritize multiple tasks, and maintain extreme accuracy under strict deadlines.
In summary, the Clinical Research Associate I position at Abbott is a high-impact Clinical Research Associate Job that offers deep exposure to international site operations. By managing the regulatory and logistical backbone of clinical trials in Gurgaon, you ensure that Abbott’s medical devices meet the highest safety and efficacy standards before reaching patients. This Bioengineering Job pathway within an Abbott Career provides the perfect environment for early-career researchers to master the nuances of global clinical regulations while contributing to a legacy of healthcare innovation.
