Clinical Trial Assistant

Roles & Responsibilities:
• Handling Regulatory and Ethics Committee (EC) documentation, submissions, tracking, and follow-ups
• Preparation and maintenance of initial submissions, amendments, and renewals as per study protocols
• Maintaining and updating Trial Master File (TMF) in compliance with ICH-GCP and sponsor requirements
• Coordinating with investigational sites for timely collection of essential documents
• Supporting study start-up activities including site feasibility, document collection, and site activation readiness
• Ensuring accurate documentation, compliance, and audit readiness throughout the clinical trial lifecycle

Qualification:
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or Clinical Research

Experience:
• 6 months to 2 years of hands-on experience in clinical research, regulatory affairs, or clinical trial coordination

Skills:
• Working knowledge of ICH-GCP guidelines and clinical trial documentation
• Experience in TMF management and EC submissions
• Strong coordination, communication, and documentation skills
• High attention to detail with ability to meet regulatory timelines

About the Organization:
Curaclin Research is a growing Clinical Research Organization (CRO) committed to conducting ethical, compliant, and high-quality clinical trials in alignment with ICH-GCP standards, supporting sites, ethics committees, and sponsors across India.