Research Associate (Clinical Research)

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

• Opportunity 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