FSP Clinical Trial Coordinator

Thermo Fisher Scientific

. Coordinate, oversee, and complete assigned trial activities according to the task matrix .

Posted 10/2/2026full-timeRemote • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in coordinating clinical trial activities, ensuring compliance with regulatory guidelines, and maintaining high-quality standards in documentation and reporting. Possesses strong organizational skills and the ability to analyze project-specific data for accuracy and efficiency.

Highest-signal resume keywords

Clinical Trial CoordinationRegulatory ComplianceData AnalysisMS Office ProficiencyGood Clinical Practices Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Database SystemsDocument ReviewETMF ManagementProject Work InstructionsRisk Management

Soft Skills

Attention to DetailOrganizational SkillsEffective CommunicationCustomer FocusNegotiation Skills

Tools & Technologies

ActivateETMFCTMS

Industry Keywords

SOPsICH Good Clinical PracticesRegulatory GuidelinesSite SelectionFeasibility Processes

About the role

Key responsibilities & impact

Coordinate, oversee, and complete assigned trial activities according to the task matrix
Perform department, internal, country, and investigator file reviews and document findings
Ensure allocated tasks are completed on time, within budget, and to a high-quality standard
Provide system support for Activate and eTMF and keep system databases current
Process documents for the Client eTMF, perform eTMF reviews, distribute communications, and provide reports
Analyze and reconcile study metrics and findings reports
Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
Support study-specific translation materials and translation quality control
Maintain knowledge of SOPs, client directives, and regulatory guidelines
Support client and internal meeting scheduling
Review and track local regulatory documents
Support risk-based monitoring activities and study documentation systems
Maintain study team lists, training requirements, system access, and project activity plans
Transmit documents to clients and centralized IRB/IEC
Maintain vendor trackers
Support regulatory submissions and regulatory compliance review packages
Work with sites to obtain site-selection documents
Coordinate internal departments to align site start-up activities with the activation critical path
Complete Site Interest Plans in CTMS and collect associated investigator/site documents
Document communications, follow-up, and survey responses in real time
Review survey data for logical, complete, and relevant responses
Collaborate with teammates and clinical personnel regarding site issues and risks
Ensure site-contact and follow-up plans are implemented and escalate concerns or non-compliance
Provide local expertise on site capacity and experience and recommend additional sites
Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
Contribute to global strategic feasibility processes and best practices
Train new personnel in processes and systems
Use local knowledge to identify and develop new sites

Requirements

What you’ll need

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Bachelor's degree preferred
Previous experience comparable to 0 to 1 year
Equivalent combination of appropriate education, training and/or directly related experience may be considered
Ability to work in a team or independently
Good organizational skills and strong attention to detail
Ability to handle multiple tasks efficiently and effectively
Ability to analyze project-specific data/systems for accuracy and efficiency
Strong customer focus
Flexibility to reprioritize workload
Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
Good English language and grammar skills and proficient local language skills as needed
Proficiency in MS Office (Word, Excel, and PowerPoint)
Ability to learn and master clinical trial database systems
Ability to successfully complete the organization's clinical training program
Effective oral and written communication skills
Essential judgment and decision-making skills
Ability to accurately follow project work instructions
Good negotiation skills
Ability to manage risk and perform risk escalation appropriately

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule