Clinical Trial Coordinator I – FSP
Company: Thermo Fisher Scientific
Job Title: Clinical Trial Coordinator I – FSP
Job ID: R-01353252
Location: North Carolina, USA (Remote)
Job Category: Clinical Research / Clinical Operations
Employment Type: Full-time
Work Mode: Fully Remote
Work Schedule: Standard (Monday–Friday)
Job Summary
Thermo Fisher Scientific (PPD Clinical Research Services) is hiring a Clinical Trial Coordinator I – FSP to support clinical study planning, execution, documentation management, regulatory readiness, vendor coordination, and day-to-day clinical trial operations. This role works closely with study managers, CROs, and internal clinical teams under the Functional Service Provider (FSP) model.
Key Responsibilities
Clinical Study Support
Support day-to-day clinical trial operations for assigned studies.
Assist in study planning and execution aligned with the Clinical Development Plan.
Collaborate with:
Clinical Operations teams
Study Managers
CROs
Internal departments
External vendors
Support critical study activities under supervision.
Documentation & Compliance
Review study documentation including:
Essential document packets
Study plans
Informed Consent Forms (ICFs)
Support regulatory inspection readiness, including:
SOP lists
Storyboard collation
Study documentation completeness
Support CTMS / TMF / study systems activities.
Maintain training records and process compliance.
Ensure adherence to:
ICH-GCP
Regulatory requirements
Clinical trial SOPs
Monitoring & Study Coordination
Support risk-based monitoring oversight.
Attend key study meetings and prepare meeting minutes where required.
Support study closeout activities including:
Financial reconciliation
Documentation finalization
Assist with vendor contract administration.
Handle ad-hoc operational study tasks.
Required Qualifications
Relevant bachelor’s degree preferred
(Exact qualification not fully specified in shared JD excerpt)
Required Experience
This appears to be an entry-to-junior clinical operations role.
Expected background:
Clinical trial support / clinical operations exposure preferred
Knowledge of:
ICH-GCP
Clinical trial workflows
CTMS / TMF systems
Required Skills
Technical Skills
Clinical Trial Coordination
Clinical Operations Support
CTMS
TMF / eTMF
Regulatory Documentation
Risk-Based Monitoring Support
Vendor Management Support
Study Closeout Activities
Financial Reconciliation Support
Microsoft Office:
Excel
Word
PowerPoint
Outlook
Domain Knowledge
ICH-GCP
Clinical Research Regulations
Clinical Trial Documentation
CRO Operations
Soft Skills
Strong communication skills
Organization
Time management
Multitasking
Deadline management
Problem-solving
Adaptability
Team collaboration
Fast learning ability
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