About medONE

medONE is a CDSCO-registered Clinical Research Organization with over two decades of experience in delivering high-quality clinical research services. The organization has strong expertise in late-phase and post-marketing studies and is progressively expanding its capabilities to support early-phase clinical research. We are committed to ethical conduct, regulatory excellence, and continuous capability building across our teams.

Role Overview

We are seeking a Clinical Research Associate (CRA) to support the execution of clinical studies in compliance with regulatory, ethical, and quality standards. The role is open to professionals with varying levels of experience; responsibilities will be aligned based on individual capability and experience.

Key Responsibilities

- Conduct or support site initiation, monitoring, and close-out visits
- Perform source data verification (SDV) and ensure data accuracy
- Review and maintain study documentation (ISF, TMF)
- Ensure compliance with protocol, SOPs, and GCP requirements
- Support safety reporting, including AE/SAE documentation
- Coordinate with investigators, site staff, and internal teams




- Maintain ISF and ensure TMF completeness and inspection readiness
- Support audit and inspection readiness activities

Eligibility Criteria

- 1–3 years of experience in clinical research, with hands-on monitoring experience
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- Strong understanding of ICH-GCP, regulatory requirements, and clinical operations
- Ability to manage multiple sites independently
- Strong communication, documentation, and organizational skills
- Willingness to travel as required

Preferred / Added Advantage

- Experience in post-marketing or late-phase studies
- Exposure to pharmacovigilance activities (AE/SAE handling)
- Familiarity with EDC, CTMS, and eTMF systems

What We Offer

- Prospect to work on diverse and meaningful clinical projects
- Clear career progression and performance-based growth
- Collaborative, quality-driven work culture
- Continuous learning and professional development

Job Types: Full-time, Permanent

Pay: ₹336,000.00 - ₹420,000.00 per year

Benefits:

- Health insurance

Work Location: In person

📌 Clinical Research Associate (India)
🏢 medONE Pharma Solutions
📍 India