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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 in managing clinical trial activities, ensuring compliance with ICH Good Clinical Practices and local regulations. Proficient in utilizing clinical trial database systems and MS Office to support project execution and documentation.
Highest-signal resume keywords
Clinical Trial CoordinationICH Good Clinical PracticesMS Office ProficiencyProject Risk CommunicationRegulatory 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
Clinical Trial CoordinationData AnalysisDocument ReviewETMF ManagementProject ManagementVendor TrackingTranslation Quality ControlMeeting OrganizationReport CompilationRegulatory Compliance
Soft Skills
Strong Organizational SkillsAttention to DetailCustomer FocusFlexibility and AdaptabilityInterpersonal Skills
Tools & Technologies
GoBaltoETMFClinical Trial Database Systems
Certifications & Qualifications
PPD Clinical Training Program
Industry Keywords
Country RegulationsSOPsWPDsNon-Clinical StudyClinical Study
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
- Communicate project risks to project leads and line manager
- Maintain study-specific documentation, team lists, training requirements, system access, activity plans, and eTMF records
- Provide system support for GoBalto and eTMF
- Support risk-based monitoring activities
- Process trial documents, perform eTMF reviews, conduct mass mailings, and provide documents and reports to internal team members
- 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
- Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites
- Assist with study-specific translation materials and translation quality control
- Attend kick-off meetings and take notes when required
- Provide administrative and technical support to the Project Team
- Act as a study lead or cross-functional liaison when required
- Support onboarding as a buddy and train new staff as needed
- Support departmental and cross-functional process improvement initiatives
- Occasional drives to site locations and potential occasional travel
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; proficiency 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
- In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient