FSP Clinical Trial Coordinator - eTMF

FSP Clinical Trial Coordinator - eTMF

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Trial Coordinator I(eTMF)

Role Summary:
The Clinical Trial Coordinator I supports the planning, execution, and administration of clinical trials by managing trial documentation, clinical systems, site activities, regulatory processes, and study tracking. The role works closely with study teams, investigators, and internal stakeholders to ensure timely, compliant, and high-quality trial delivery.

Key Responsibilities

• Maintain and manage TMF/eTMF and ISF documentation, ensuring completeness and audit readiness.
• Support study setup and execution by coordinating trial materials, site documentation, and regulatory submissions.
• Manage clinical systems (CTMS, Activate, eTMF), study trackers, reports, and access management.
• Support site qualification, feasibility, site start-up, and investigator documentation activities.
• Coordinate study supplies, vendor interactions, logistics, and site communications.
• Review study metrics, maintain databases, and ensure timely completion of assigned tasks. 
• Collaborate with cross-functional teams to ensure compliance with ICH-GCP, SOPs, and regulatory requirements.

Required Skills

• Clinical Trial Coordination & Clinical Operations
• eTMF/TMF and ISF Management
• CTMS, Activate, and Clinical Systems
• Regulatory Documentation & Site Start-up Support
• Feasibility and Site Qualification Activities
• ICH-GCP and Regulatory Compliance
• MS Office (Excel, Word, PowerPoint, Outlook)
• Strong Communication, Organization, and Documentation Skills

Education & Experience

• Bachelor's degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field.
• 1- 3 years of experience in Clinical Research, Clinical Operations, or Trial Coordination.
• Understanding of ICH-GCP, clinical trial processes, and regulatory requirements preferred.
• Hands on work experience in global clinical trials.
• Hands on working experience in eTMF system preferably Veeva.

Hands on working experience in taking minutes of meetings of study calls

Experience Level

Mid Level