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Clinical Trial Coordinator
Thermo Fisher Scientific. Coordinate, oversee, and complete assigned trial activities according to the task matrix .
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 managing trial activities, ensuring compliance with ICH Good Clinical Practices and local regulations. Proficient in maintaining study documentation and supporting cross-functional teams to enhance project execution and efficiency.
Highest-signal resume keywords
Clinical Trial AdministrationICH Good Clinical PracticesProject-Specific Data AnalysisMS Office ProficiencyRegulatory Document Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Trial Master File ManagementDocument ProcessingStudy Metrics AnalysisVendor TrackingTranslation Quality Control
Soft Skills
Strong Organizational SkillsAttention to DetailCustomer FocusFlexibility and AdaptabilityInterpersonal Skills
Tools & Technologies
GoBaltoETMF SystemClinical Trial Database Systems
Certifications & Qualifications
PPD Clinical Training Program
Industry Keywords
Country RegulationsSOPsWPDsInvestigator Site FileNon-Clinical Study Supplies
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
- Maintain study-specific documentation, systems, tools, trackers, study team lists, training requirements, system access, and project activity plans
- Keep the electronic Trial Master File up to date and provide GoBalto and eTMF system support
- Support risk-based monitoring activities
- Perform trial administration, including document processing, eTMF reviews, mass mailings, communications, and reports
- Schedule and organize client and internal meetings and complete meeting minutes
- Review and track local regulatory documents
- Transmit documents to the client and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports and assist with resolving site-documentation findings
- Maintain vendor trackers
- Assist with coordination, compilation, and distribution of Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Assist with study-specific translation materials and translation quality control
- Attend kick-off meetings and take notes when required
- Act as a cross-functional liaison and potential study lead
- Support onboarding as a buddy and provide training to new staff
- Support departmental and cross-functional process-improvement initiatives
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 at least 4 years
- Ability to work in a team or independently as required
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation skills
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude with effective strong interpersonal skills