FSP Clinical Trial Coordinator - Site Record Coordination

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Trial Coordinator (Site Record Coordination)

Role Summary
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. The role collaborates with study teams, investigators, and cross-functional stakeholders to support study start-up, conduct, and closeout activities.

Key Responsibilities

• 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.

Required Skills

• Clinical Trial Operations
• TMF/eTMF & ISF Management
• CTMS and Clinical Trial Systems
• Site Collaboration & Site Documentation
• ICH-GCP and Good Documentation Practice
• Regulatory Documentation
• Communication & Stakeholder Management
• Microsoft Office Suite (Excel, Word, PowerPoint)

Education & Experience

• Bachelor's degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related discipline.
• 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 eTMF system preferably Veeva.
• Hands on working experience in managing site related files and site collaborations ( preferably for Europe and US sites)