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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 multiple tasks, analyzing project-specific data, and ensuring compliance with regulatory guidelines and SOPs.
Highest-signal resume keywords
Clinical Trial Database SystemsICH Good Clinical PracticesMS Office ProficiencyRegulatory SubmissionsAttention to Detail
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 AnalysisDocument ReviewSite Activation SupportFile ReviewRegulatory ComplianceProject ManagementRisk ManagementTranslation Quality ControlSite SelectionFeasibility Analysis
Soft Skills
Organizational SkillsEffective CommunicationCustomer FocusNegotiation SkillsFlexibility
Tools & Technologies
ETMFActivateCTMSDatabase Management Systems
Industry Keywords
SOPsWPDsClinical TrialsRegulatory GuidelinesAudit ReadinessInvestigator Site FileSite CapacityGlobal Strategic Feasibility
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
- Support development of site activation critical paths
- Develop and review site lists for feasibility activities and provide local input into 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 allocated tasks are completed on time, within budget and to a high-quality standard
- Provide system support for Activate and eTMF and keep databases current
- Process documents for client eTMF, perform eTMF reviews, distribute mailings and communications, and provide documents and 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
- Maintain knowledge of SOPs, client directives and regulatory guidelines
- Support client/internal meeting scheduling and local regulatory document tracking
- Support RBM activities and study documentation/system maintenance
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions and site selection document collection
- 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
- 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 regarding site issues and risks
- Maintain 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 strategic 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
- An equivalency consisting of appropriate education, training and/or directly related experience may be considered
- Ability to work independently or in a team
- Good organizational skills and strong attention to detail
- Ability to manage multiple tasks efficiently and effectively
- Ability to analyze project-specific data/systems accurately and efficiently
- Strong customer focus
- Flexibility to reprioritize workload according to changing project timelines
- 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, including Word, Excel and PowerPoint
- Ability to learn and master clinical trial database systems
- Ability to complete the organization's clinical training program
- Effective oral and written communication skills
- Essential judgment and decision-making skills
- Ability to accurately follow project work instructions
- Good negotiation skills
- Ability to manage risk and perform appropriate risk escalation
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule