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Central Cra (Clinical Research Associate)- Registries

3+ years
₹9–13 LPA
10 May 23, 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
Job Type: Full-Time, Permanent
Travel Requirements: As per business needs
Salary Estimate: ₹9–13 LPA based on experience and industry standards

About the Role:
Join Sanofi’s mission to deliver life-saving innovations in immunology and chronic disease management. As a Central CRA focusing on rare disease registries, you will act as the key liaison between Sanofi and investigational sites, driving quality data collection, compliance, and site support throughout the trial lifecycle.


Key Responsibilities:

Feasibility and Site Start-Up:

  • Participate in site selection with the Registries Team.

  • Support the collection and quality control of regulatory documents.

  • Customize and review ICFs per local requirements.

  • Facilitate ethics committee communication and insurance certificate preparation.

  • Assist in site contract processing and eTMF documentation.

Site Monitoring:

  • Conduct remote and onsite site visits (selection, initiation, monitoring, close-out).

  • Ensure adherence to study protocols, GCP, and SOPs.

  • Monitor trial progress and ensure accurate and timely data entry in eCRFs.

  • Liaise with vendors and maintain site readiness for audits.

Data and Site Management:

  • Perform regular source data verification and query resolution.

  • Monitor patient recruitment and retention progress.

  • Train site staff on protocol and systems usage.

  • Ensure safety reporting compliance and CAPA implementation for deviations.

Study Administration & Stakeholder Communication:

  • Maintain updated trackers, databases, and contribute to TMF compliance.

  • Participate in team meetings, audits, and inspections.

  • Collaborate with internal teams and site personnel for study coordination.

  • Facilitate effective communication, manage conflicts, and uphold ethical standards.


Qualifications and Experience:

Required:

  • Bachelor’s/Master’s degree in Life Sciences, Pharmacy, or related field.

  • Minimum 3 years of experience in clinical research and trial monitoring.

  • Familiarity with rare diseases, RWE studies, or observational study design.

Preferred:

  • Experience in global projects and international matrix environments.

  • Knowledge of GCP, regulatory guidelines (FDA, EMA), and ethical considerations.


Technical and Soft Skills:

  • Technical: GCP, regulatory compliance, data management, eCRF systems, Microsoft Office proficiency.

  • Soft Skills: Effective communication, time management, adaptability, problem-solving, interpersonal sensitivity, ethical decision-making.


Performance Expectations:

  • Maintain site and study readiness for audits/inspections.

  • Ensure high-quality, timely data collection and issue resolution.

  • Foster robust collaboration across stakeholders.

  • Demonstrate continuous professional development and training participation.


Sanofi Advantage:
Be part of a future-shaping journey where technology meets patient care. Join us in delivering better access to healthcare and improving lives globally.