Thermo Fisher Scientific
FSP Clinical Trial Coordinator - eTMF
Skills
Job description
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