Job Title: Clinical Trials Administrator
Department: Study Support
Location: Mumbai, India
Hours Per Week: 40 hours
Schedule: Days, Monday – Friday

SUMMARY
The Clinical Trials Administrator [CTA] is responsible for coordinating clinical trial activities from study set-up through closeout, ensuring accurate documentation, data quality, regulatory compliance, and timely project deliverables. Collaborates with clients, investigator sites, laboratory teams, and vendors to support study operations, LIMS set-up, quality control, and clinical trial supply logistics while maintaining service standards and a positive client experience.

RESPONSIBILITIES
Project Management
• Review Clinical Trial Protocols and assist with protocol set-up functions as required.
Develops the Protocol Test Summary (PTS), Global Laboratory Specification Document (GLSD), Investigator Laboratory Manual and protocol specific operating procedures
• Support day to day project related activities once the study is live
• Coordination with Sponsor, CRO & Alliance laboratory for each project




• Participate in study conference calls with clients
• Take minutes
• Summarize actions from the meeting, study metrics / trend monitoring
• Generate and customises reports to monitor study metrics / trends (i.e. Action Items, supplies shipped, cancelled tests, etc.)
• Interface with client, sponsor, CRO
• Query resolution
• DIF follow up with client / site contacts
• Resolving unlabelled samples
• Add history and close action items based on responses from sites / clients
• Study binder management
• Assist PM with binder management / file documents in binder (including binders that have been archived)
• Perform secondary binder QC review
• Notify PM when binder has been finalized and submits the binder to PM for review
• Site list management
• Adding, removing, and modifying sites / contacts into LabStar WIN
• Site support / incoming calls / Alert Calls and emails
• Ensure that the data cleaning & quality control of

📌 Clinical Trials Administrator (India)
🏢 Rochester Regional Health
📍 India