Clinical Trial Coordinator

Thermo Fisher Scientific

. Provide administrative and technical support to the Project Team .

Posted 10/23/2026full-timeRemote • MalaysiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong organizational skills and attention to detail while providing administrative and technical support for clinical trial activities. Proficient in managing project-specific data, regulatory compliance, and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Trial Database SystemsICH Good Clinical PracticesMS Office ProficiencyRegulatory ComplianceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisFile ReviewSite ActivationDocument ManagementRisk Management

Soft Skills

Attention to DetailTeam CollaborationEffective CommunicationNegotiation SkillsFlexibility

Tools & Technologies

ETMF SystemsSOPsCountry RegulationsInvestigator Site File

Industry Keywords

Audit ReadinessFeasibility ActivitiesClinical Training ProgramSite SelectionVendor Management

About the role

Key responsibilities & impact

Provide administrative and technical support to the Project Team
Support audit readiness through scheduled file reviews according to SOPs and department guidance
Support site activation activities and development of site activation critical paths
Develop and review site lists for feasibility activities and contribute local input to site tiering
Coordinate, oversee, and complete assigned trial activities according to task matrices
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
Support Activate and eTMF systems and keep databases current
Process and review eTMF documents, distribute communications, and provide documents and reports
Analyze and reconcile study metrics and findings reports
Coordinate Investigator Site File, Pharmacy binder, and non-clinical study supply materials
Support translation materials and translation quality control
Conduct on-site feasibility visits where applicable in Asia Pacific
Schedule client and internal meetings as needed
Review and track local regulatory documents
Maintain study documentation, team lists, training requirements, system access, and activity plans
Transmit documents to clients and centralized IRB/IEC
Maintain vendor trackers
Support regulatory submissions and prepare regulatory compliance review packages
Work with sites to obtain site-selection documents
Coordinate with internal departments to align site start-up activities
Complete Site Interest Plans 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 resolve site issues and risks
Manage site contact and follow-up plans 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 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
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year
Bachelor's degree preferred
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
Proficient 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
Judgment and decision-making skills
Ability to follow project work instructions accurately
Good negotiation skills
Ability to manage risk and perform risk escalation appropriately
Occasional travel and drives to site locations may be required

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
Training and onboarding support
Opportunity to act as a buddy and train new staff
Potential professional development through clinical training program