Clinical Trial Coordinator II

Thermo Fisher Scientific

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

Posted 10/13/2026full-timeRemote • North Carolina • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong organizational skills and attention to detail while managing clinical trial activities, ensuring compliance with ICH Good Clinical Practices and relevant regulations. Proficient in MS Office and clinical trial database systems, with effective communication and interpersonal skills to collaborate with diverse teams.

Highest-signal resume keywords

Clinical Trial CoordinationRegulatory Compliance KnowledgeMS Office ProficiencyStrong Organizational SkillsEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial CoordinationRegulatory Compliance KnowledgeData AnalysisDocument ReviewETMF ManagementSite SelectionClinical Training Program CompletionBasic Medical TerminologyProject ManagementRisk Management

Soft Skills

Strong Customer FocusInterpersonal SkillsNegotiation SkillsFlexibility and AdaptabilityAttention to Detail

Tools & Technologies

ETMFCTMSClinical Trial Database SystemsMS Office (Word, Excel, PowerPoint)

Industry Keywords

ICH Good Clinical PracticesSOPsWPDsLocal Health SystemsClinical Trial Activities

Tech Stack

Tools & technologies

Google Cloud Platform

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
Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads and line manager
Process documents sent to the client eTMF, perform eTMF reviews, distribute mailings and communications, and provide reports to internal teams
Review and track local regulatory documents
Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings
Maintain vendor trackers and study status information in databases
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
Provide technical and administrative project support with internal departments and team members
Maintain knowledge of SOPs, client directives, and regulatory guidelines
Maintain study documentation, team lists, training requirements, system access, activity plans, and eTMF schedules
Provide system support for Activate and eTMF and may support RBM activities
Transmit documents to clients and centralized IRB/IEC
Attend kickoff meetings, take notes, and support scheduling and meeting minutes
Coordinate with internal departments to align site start-up activities with the site activation critical path
Assist with regulatory compliance review packages and regulatory submissions
Obtain site-selection documents and develop site lists using internal and external research
Maintain investigator and site staff contact details in company systems
Complete Site Interest Plans in CTMS and document site communications and survey responses
Review survey data for logical, complete, and relevant responses
Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and follow-up plans
Act as a local expert on site capacity and experience; support site tiering and recommend additional sites
Conduct physician and site-personnel interviews to obtain protocol-level input for trial optimization
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 and support departmental process improvements

Requirements

What you’ll need

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Ability to work independently or in a team environment
Strong organizational skills and attention to detail; ability to handle multiple tasks efficiently
Ability to analyze project-specific data and systems for accuracy and efficiency
Strong customer focus
Flexibility and adaptability to changing project timelines
Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
Excellent English language and grammar skills and proficient local language skills as needed
Good presentation skills
Proficiency in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems
Ability to successfully complete the organization's clinical training program
Effective oral and written communication skills, including communication with medical personnel
Strong interpersonal, negotiation, relationship-building, and risk-management skills
Basic medical/therapeutic area and medical terminology knowledge
Basic organizational, planning, and local health systems knowledge
Ability to work in a matrix environment
Ability to attain and maintain knowledge of GCP and applicable SOPs
Occasional driving to site locations and potential occasional travel
Bachelor's degree preferred

Benefits

Comp & perks

Fully remote work arrangement
Full-time employment
Standard Monday–Friday work schedule