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 local regulations. Proficient in MS Office and clinical trial database systems, with effective communication and relationship-building abilities.

Highest-signal resume keywords

Clinical Trial ManagementICH Good Clinical PracticesMS Office ProficiencyRegulatory ComplianceOrganizational Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Database SystemsDocument ReviewData AnalysisProject ManagementRisk Management

Soft Skills

Attention to DetailTeam CollaborationEffective CommunicationCustomer FocusFlexibility

Tools & Technologies

ETMF SystemsCTMSMS WordMS ExcelMS PowerPoint

Industry Keywords

SOPsWPDsLocal Health SystemsMedical TerminologyRegulatory Submissions

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
Ensure allocated tasks are completed on time, within budget, and to a high-quality standard
Communicate project risks to project leads and line manager
Process documents sent to the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members
Review and track local regulatory documents
Analyze and reconcile study metrics and findings reports
Maintain vendor trackers
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 in collaboration with internal departments and team members
Maintain knowledge of SOPs, client directives, and regulatory guidelines
Maintain accurate and current trial status information in databases
Develop and maintain relationships with client local affiliates where applicable
Train new personnel in processes and systems
Maintain study documentation, team lists, training requirements, system access, and project activity trackers
Support Activate and eTMF systems, RBM activities, document transmission, meetings, meeting minutes, and scheduling
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 directly from sites when needed
Develop site lists and maintain investigator and site staff contact details
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 and risks
Ensure effective site contact and follow-up plans and escalate non-compliance
Gather local knowledge about site capacity and experience and recommend additional sites
Conduct phone interviews with physicians and site personnel to obtain protocol-level input
Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
Contribute to global strategic feasibility processes and best practices

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 in a team or independently
Strong organizational skills and 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 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)
Ability to learn and master clinical trial database systems and appropriate software
Ability to successfully complete the organization's clinical training program
Effective oral and written communication skills, including communication with medical personnel
Good negotiation skills
Basic medical/therapeutic area and medical terminology knowledge
Basic organizational and planning skills
Basic knowledge of local health systems
Working knowledge of GCP and applicable SOPs
Ability to work in a matrix environment
Relationship-building ability
Independent thinking
Ability to manage risk and perform appropriate risk escalation

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule