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Clinical Trial Coordinator
Thermo Fisher Scientific. Provide administrative and technical support to the Project Team .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisFile ReviewSite Activation SupportDocument ProcessingRisk ManagementFeasibility AssessmentRegulatory Submission PreparationTask CoordinationTranslation Quality ControlSurvey Data Review
Soft Skills
Attention to DetailTeam CollaborationCustomer FocusNegotiation SkillsEffective Communication
Tools & Technologies
ETMF SystemsCTMSVendor TrackersSOPsWPDs
Industry Keywords
Audit ReadinessSite SelectionClinical Training ProgramAsia Pacific Feasibility VisitsLocal Regulatory Knowledge
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
- Provide administrative support for site activation activities
- Help develop critical paths for site activation
- Develop and review site lists for feasibility activities and provide local input into site tiering
- Coordinate 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
- Support Activate and eTMF systems and keep databases current
- Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide reports
- Analyze and reconcile study metrics and findings reports
- Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- 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 as needed
- Support RBM activities and study-specific documentation and systems
- Transmit documents to the client and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions and site start-up activities
- Work with sites to obtain site-selection documents
- Prepare regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities
- Complete Site Interest Plans in CTMS and collect associated investigator/site documents as needed
- 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 on deadlines, site issues and risks
- Maintain site contact and follow-up plans and escalate 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
- 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 and systems accurately
- 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
- Proficient local language skills as needed
- Proficiency in MS Office (Word, Excel, 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
- Essential judgment and decision-making skills
- Ability to follow project work instructions accurately
- Good negotiation skills
- Ability to manage risk and perform risk escalation appropriately
Benefits
Comp & perks- Fully remote work arrangement
- Full-time employment
- Standard Monday–Friday work schedule
- Potential occasional travel
- Training and onboarding support
- Opportunity to work with global pharmaceutical and biotech companies
- Professional development through clinical training program