FSP Clinical Trial Coordinator I

Thermo Fisher Scientific

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

Posted 10/16/2026full-timeRemote • MexicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in coordinating clinical trial activities, maintaining compliance with regulatory guidelines, and managing project documentation. Exhibits strong organizational skills, attention to detail, and effective communication abilities to support study-specific tasks and team collaboration.

Highest-signal resume keywords

Clinical Trial CoordinationRegulatory Compliance KnowledgeMS Office ProficiencyAttention to DetailEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Database SystemsProject Data AnalysisDocument ReviewRisk ManagementSite Selection Documentation

Soft Skills

Organizational SkillsCustomer FocusIndependent ThinkingNegotiation SkillsFlexibility

Tools & Technologies

ETMFActivateCTMS

Industry Keywords

ICH Good Clinical PracticesSOPsWPDsRegulatory SubmissionsSite Activation

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 risks to project leads
Provide system support for Activate and eTMF and keep system databases current
Process documents for client eTMF, perform eTMF reviews, distribute mass mailings and communications, and provide documents and reports to internal team members
Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings
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
Conduct on-site feasibility visits where applicable for Asia Pacific projects
Support client and internal meeting scheduling
Review and track local regulatory documents and support RBM activities
Maintain study documentation and systems, including 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 site start-up activities
Work directly with sites to obtain site-selection documents
Prepare regulatory compliance review packages
Coordinate with internal departments to align site start-up activities with the site activation critical path
Complete Site Interest Plans in CTMS and collect and deliver associated investigator and site personnel documents
Document all site-contact communications, attempts, 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 project deadlines and address site issues and risks
Maintain efficient site-contact and follow-up plans; ensure compliance and escalate concerns or non-compliance
Act as a local expert on site capacity and experience and recommend additional sites
Liaise with Global Investigator Services to resolve investigator queries and maintain account and 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 providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail, with 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 to meet changing project timelines
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) and ability to 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
Independent thinking
Ability to manage risk and perform risk escalation appropriately
Occasional travel may be required
In some cases, an equivalency consisting of appropriate education, training and/or directly related experience may be considered sufficient

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule