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Thermo Fisher Scientific

Principal Clinical Trial Coordinator – FSP

Thermo Fisher Scientific

Principal Clinical Trial Coordinator handling administrative support and project coordination for clinical trials at Thermo Fisher Scientific. Overseeing study milestones and coordinating training and resources.

Posted 7/31/2026full-timeRemote • North Carolina • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in project coordination and management within clinical settings, ensuring compliance with client expectations and regulatory standards. Proficient in handling eTMF activities, training coordination, and logistical support for clinical projects.

Highest-signal resume keywords
Project CoordinationETMF ManagementTraining SupportQuality AssuranceFinancial Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Project ManagementETMF ActivitiesEDP/RCR Package PreparationTMF ReviewClinical Project Coordination
Soft Skills
Effective CommunicationCollaborationProblem-Solving
Industry Keywords
Clinical TrialsRegulatory ComplianceInvestigator MeetingsTherapeutic KnowledgeAudit Preparation

About the role

Key responsibilities & impact
  • Attends kick-off meetings and supports training to team members, investigators, or clients as needed
  • Serves as study eTMF lead, handling client integration and (e)TMF activities
  • Provides technical and administrative support for project coordination to meet study-level milestone targets
  • Assists with preparation and review of EDP/RCR packages
  • Supports development of country or site-specific documents
  • Support study close-out activities including final TMF Review and TMF certification form (DEV-FORM-1939) completion
  • Support with preparations for Investigator Meetings
  • Maintaining and coordinating the logistical aspects of clinical projects
  • Initiates the preparation of all project/program plans required by client contracts
  • Coordinates project/program/protocol specific and therapeutic area training needs
  • Tracks and follows up on all training, non-disclosure agreements, and security clearance requests
  • Performs basic project financial management tasks as assigned
  • Acts as task order/work assignment lead on small scopes of work for contracts/projects of low complexity
  • Escalates compliance to established project-specific parameters and client expectations
  • As Project Specialists ensures the contracted services and expectations of assigned projects are carried out
  • Maintaining timely and effective communication among team members, site staff
  • Providing support for quality assurance activities, including preparation for audits and internal review
  • Contributes to discussions with teammates to support collaboration and best practices
  • Expands therapeutic knowledge and expertise

Requirements

What you’ll need
  • Bachelor's degree preferred
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)

Benefits

Comp & perks
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options