Clinical Trial Assistant

Role & Responsibilities
• Handle regulatory and Ethics Committee (EC) documentation, submissions, tracking, and follow-ups
• Prepare and manage initial submissions, amendments, and renewals as per study protocols
• Maintain and update the Trial Master File (TMF) in compliance with ICH-GCP and sponsor requirements
• Coordinate with investigational sites for timely collection of essential study documents
• Support study start-up activities including site feasibility and activation readiness
• Ensure accuracy, completeness, and audit readiness of trial documentation
• Assist in ongoing regulatory maintenance 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 experience in clinical trial coordination or regulatory support

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

About the Company
• Curaclin Research is a growing clinical research organization (CRO), Supports ethical, compliant, and high-quality clinical trial, Works closely with investigational sites, ethics committees, and sponsors.