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)

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.