Samahitha Research Solutions is Hiring Clinical Trial Assistant (CTA)

Designation: Clinical Trial Assistant (CTA)
Skill Required: Clinical Operations
Years of Experience: 3 months to one year
Job Location: Bengaluru, Karnataka
Looking for immediate Joiner

Clinical Operations Support
• Documentation Management: Ensures accurate, timely filing of essential documents in the Trial Master File (TMF) and Study Management File (SMF) to comply with Good Clinical Practice (GCP) standards and regulatory requirements.
• Site Communication: Acts as a point of contact for investigational sites, assisting with coordination and communication to ensure study-related information is disseminated effectively and efficiently.
• Regulatory Compliance: Assists in preparing and submitting documents to regulatory authorities, ethics committees, or institutional review boards as required, following approval by the Project Manager.
• Meeting Coordination: Organizes and schedules project team meetings, site initiation visits, and monitoring visits, ensuring logistics are managed and relevant documents are prepared.

Data Entry and Database Management
• Data Collection and Tracking: Assists in the collection, entry, and quality control of data in study databases, verifying data accuracy and completeness under supervision.
• Tracking Logs: Maintains up-to-date logs for essential activities, including site monitoring visits, document receipt, and adverse event tracking.

Study Supply Management
• Inventory Tracking: Supports inventory management, tracking investigational drug supplies, and other study materials, coordinating timely shipments to investigational sites.
• Site Supplies: Assists in the preparation and shipping of study supplies to sites, maintaining accurate records and logs of all dispatches.

Administrative Tasks
• Invoice Processing: Helps manage invoices and site payments by tracking project-related financial records.
• Training Support: Assists in organizing training sessions for site staff on protocols and compliance, preparing training materials and resources as needed.
Regular Job description
 
• Fills/Files relevant documents in TMF and / or SMF, under direct supervision of Project Manager / Coordinating CRA and Clinical Research Associate (prepares the trial master file and investigator’s file including all GCP-related documentation; manages all study and site related documents before and during the course of the study – i.e. drug accounting documents, correspondence, monitoring reports, contact reports and other study related documents)
• Generates and maintains databases for appropriate study administration
• Prepares and submits regular study status reports to the sponsor after approval from the Project Manager / Coordinating CRA
• Support Project Manager / Coordinating CRA and CRAs in all relevant study activities – e.g. shipment of supplies to the investigational sites