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Central Cra (Clinical Research Associate)- Registries

3+ years
Not Disclosed
10 June 6, 2025
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

 

Job Title: Central CRA (Clinical Research Associate) – Registries

Location: Hyderabad, India
Work Mode: Hybrid (Remote site management + on-site where applicable)
Job Type: Full-time, Permanent
Experience Level: Mid to Senior Level (3+ years)
Salary: Not specified


Job Summary

Sanofi is seeking a highly motivated Central Clinical Research Associate (CRA) to support rare disease registry studies. Based in Hyderabad, this role plays a vital part in clinical research operations—handling site management, data quality, compliance with ICH-GCP, and coordination with global stakeholders. If you're passionate about improving health outcomes through high-quality real-world evidence and patient registry data, this role offers an exceptional platform to contribute meaningfully.


Key Responsibilities

  • Act as the primary contact for site staff involved in rare disease registries

  • Support site feasibility and selection activities with the Registries team

  • Manage study start-up: site contracts, ethics submissions, ICF customization, insurance documentation

  • Conduct remote and on-site monitoring visits (Site Selection, Initiation, Monitoring, Close-Out)

  • Ensure site compliance with GCP, regulatory, and internal SOPs

  • Oversee eCRF completion and query resolution

  • Maintain eTMF documentation throughout study lifecycle

  • Monitor patient recruitment, enrolment, and retention

  • Support regulatory audits and inspections with an “audit readiness” mindset

  • Coordinate with Data Management and Safety teams

  • Liaise with vendors and investigators to ensure seamless study execution


Required Skills & Qualifications

  • 3+ years of experience in clinical trial monitoring or observational studies

  • Bachelor's or Master’s in Life Sciences, Pharmacy, or related field

  • Strong working knowledge of GCP, ICH-GCP, and clinical trial processes

  • Experience in data management, protocol compliance, and safety reporting

  • Familiar with eTMF, eCRF, and study start-up processes

  • Proficiency in Microsoft Office tools

  • Strong communication and interpersonal skills

  • Experience in global or matrixed environments preferred

  • Excellent command of written and spoken English


Perks & Benefits

  • Opportunity to work with a global leader in rare disease and chronic care research

  • Exposure to advanced digital tools and global health registries

  • Structured learning and development programs

  • Collaborative and inclusive workplace culture

  • Competitive compensation (exact salary not disclosed)


About Sanofi

Sanofi is a global biopharmaceutical company committed to human health. With a legacy of innovation in immunology, diabetes, cardiovascular disease, and rare diseases, Sanofi drives progress by harnessing AI, digital health, and global expertise to transform patient care. Join Sanofi and be part of a mission to chase the miracles of science.


Call to Action

Are you ready to contribute to cutting-edge clinical research and real-world evidence generation?
Apply now and accelerate your impact on global health with Sanofi in Hyderabad.