Clinical Trial Coordinator I

Thermo Fisher Scientific

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

Posted 10/15/2026full-timeRemote • MexicoMid-LevelSeniorWebsite

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 regulatory guidelines and effective communication with stakeholders. Proficient in analyzing project-specific data and utilizing clinical trial database systems to support study operations.

Highest-signal resume keywords

Clinical Trial Database SystemsRegulatory ComplianceGood Clinical PracticesMS Office ProficiencyProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Database SystemsRegulatory ComplianceGood Clinical PracticesMS Office ProficiencyData AnalysisDocument ReviewRisk ManagementTranslation Quality ControlSite SelectionSOP Knowledge

Soft Skills

Attention to DetailOrganizational SkillsEffective CommunicationTeam CollaborationNegotiation Skills

Tools & Technologies

ETMFActivateCTMS

Industry Keywords

Clinical TrialsRegulatory GuidelinesSOPsCountry RegulationsInvestigator Site File

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 a high-quality standard
Communicate project risks proactively to project leads
Provide system support for Activate and eTMF and keep system databases current
Process documents for Client (e)TMF, perform (e)TMF reviews, distribute mass mailings and communications, and provide documents and reports to internal teams
Analyze and reconcile study metrics and findings reports
Assist with resolving findings related to site documentation
Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
Assist with 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 RBM activities and study-specific documentation and systems
Maintain study team lists, training requirement tracking, system access management and project activity plans
Transmit documents to clients and centralized IRB/IEC
Maintain vendor trackers
Support regulatory submissions and site start-up activities
Work directly with sites to obtain site-selection documents
Assist with regulatory compliance review packages
Complete Site Interest Plans in CTMS and collect associated investigator and site personnel documents
Document site communications, follow-ups and survey responses in real time
Review survey data for logical, complete and relevant responses
Collaborate with teammates and clinical personnel to meet deadlines and address site issues and risks
Maintain plans for site contact and follow-up 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
Conduct on-site feasibility visits where applicable for Asia Pacific roles
Occasional driving to site locations and potential travel

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, 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 complete the organization's clinical training program
Effective oral and written communication skills
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