💥 medONE Solution – Clinical Research Associate (CRA) Hiring
📍 Location: Gurugram, Haryana (Delhi NCR)
📝 Job Code: MED-CRA-001-2026
⏰ Employment Type: Full-Time
🏢 Organization: medONE Solution (COSCO-registered CRO)
Position Overview
Join medONE Solution as a Clinical Research Associate to support clinical studies in compliance with ICH-GCP, SOPs, and regulatory guidelines. This role provides exposure to end-to-end clinical trial operations, audits, and regulatory inspections.
Key Responsibilities
- Conduct site monitoring visits and routine clinical trial oversight
- Perform Source Data Verification (SDV) to ensure data accuracy
- Review and maintain essential study documents (ISF, TMF)
- Ensure compliance with study protocols, SOPs, and ICH-GCP requirements
- Support safety reporting, including AE and SAE documentation
- Coordinate with investigators, sponsors, and internal study teams
- Maintain inspection readiness and TMF completeness
- Support audits and regulatory inspections
Eligibility Criteria
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- Hands-on experience in clinical research monitoring
- Strong knowledge of ICH-GCP, regulatory requirements, and clinical operations
- Ability to manage multiple clinical trial sites independently
- Excellent communication, documentation, and organizational skills
- Willingness to travel as required
Preferred / Added Advantage
- Experience in post-marketing or late-phase clinical studies
- Familiarity with EDC, CTMS, and eTMF systems
- Exposure to pharmacovigilance activities (AE/SAE handling)
Benefits
- Exposure to diverse clinical research projects
- Performance-based career growth and progression
- Collaborative, quality-driven work culture
- Continuous learning and professional development
How to Apply
📩 Email your CV to medONE Solution
📌 Subject Line: MED-CRA-001-2026
