FSP Clinical Trial Coordinator - Site Record Coordination

Overview

The Clinical Trial Coordinator I supports clinical trial operations by managing site documentation, TMF/eTMF activities, clinical systems, site communications, and study records to ensure timely, compliant, and high-quality trial execution.

What you'll do

• Plan, distribute, collect, and track site records through Site Collaboration tools and ensure timely TMF completion.
• Perform quality reviews of study documentation and maintain TMF/eTMF, ISF, and study records.
• Support clinical systems including CTMS, Activate, and eTMF, ensuring databases and trackers remain current.
• Coordinate with sites and internal teams for document collection, site start-up, feasibility, and regulatory activities.
• Review study metrics, resolve documentation findings, and communicate site-related risks and updates.
• Support vendor management, regulatory submissions, and site communication activities.
• Maintain compliance with ICH-GCP, SOPs, Good Documentation Practices, and applicable regulations.

What you'll need

• Skills in clinical trial operations, TMF/eTMF and ISF management, and CTMS and clinical trial systems.
• Skills in site collaboration and site documentation, ICH-GCP and Good Documentation Practice, and regulatory documentation.
• Communication and stakeholder management skills.
• Microsoft Office Suite (Excel, Word, PowerPoint).
• 1-3 years of experience in Clinical Research, Clinical Operations, TMF/eTMF, Clinical Trial Coordination, or Trial Support functions.
• Hands-on work experience in global clinical trials.
• Hands-on working experience in managing site related files and site collaborations (preferably for Europe and US sites).

Nice to have

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related discipline.
• Hands-on working experience in eTMF system, preferably Veeva.

Details

• Work schedule: Standard (Mon-Fri).
• Environmental conditions: Office.
• Location: Mumbai, India.