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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 Systems SupportRegulatory Compliance KnowledgeMS Office ProficiencyAttention to DetailEffective Communication Skills
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 Database SystemsProject-Specific Data AnalysisRegulatory Document ReviewSite Activation ActivitiesAudit Readiness Support
Soft Skills
Team CollaborationCustomer FocusFlexibilityJudgment and Decision-MakingNegotiation Skills
Tools & Technologies
ETMFActivateMS Office (Word, Excel, PowerPoint)
Industry Keywords
ICH Good Clinical PracticesSOPsWPDsSite TieringRisk 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
- Provide administrative support for site activation activities and critical-path development
- Develop and review site lists for feasibility activities and contribute to site tiering
- Coordinate, oversee and complete assigned trial activities according to the task matrix
- Perform department, internal, country and investigator file reviews and document findings
- Ensure assigned tasks are completed on time, within budget and to quality standards
- Provide support for Activate, eTMF and other clinical trial systems
- Process trial documents, perform eTMF reviews, distribute communications, and provide reports
- Analyze and reconcile study metrics and findings reports
- Coordinate and distribute Investigator Site File and Pharmacy binder materials and study supplies
- Support study-specific translation materials and translation quality control
- Review and track local regulatory documents
- Support RBM activities and study documentation maintenance
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers and support regulatory submissions
- Obtain site-selection documents directly from sites
- Prepare regulatory compliance review packages
- Coordinate internal departments to align site start-up activities with the activation critical path
- Complete Site Interest Plans and collect associated investigator/site documents when applicable
- Document site communications, follow-ups and survey responses in real time
- Review survey data for completeness, logic and relevance
- Collaborate with teammates and clinical personnel regarding site issues, risks and deadlines
- Coordinate site contact and follow-up plans 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 contact information
- Contribute to global feasibility processes and best practices
- Train new personnel in processes and systems
- Contribute 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 analyze project-specific data/systems
- 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
- Proficiency in MS Office (Word, Excel, and PowerPoint)
- Ability to learn clinical trial database systems
- Ability to 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 driving to site locations and potential occasional travel
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule