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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 analyzing project-specific data and maintaining compliance with applicable regulations and best practices.
Highest-signal resume keywords
Clinical Trial Database SystemsICH Good Clinical PracticesMS Office ProficiencyRegulatory ComplianceProject Data Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Activation SupportDocument ManagementFeasibility AnalysisRisk ManagementData Reconciliation
Soft Skills
Effective CommunicationTeam CollaborationOrganizational SkillsCustomer FocusFlexibility
Tools & Technologies
ETMF SystemsCTMSVendor Trackers
Certifications & Qualifications
High School DiplomaBachelor's Degree Preferred
Industry Keywords
Country RegulationsSOPsWPDsClinical Training Program
About the role
Key responsibilities & impact- Provide administrative and technical support to the Project Team
- Support audit readiness through scheduled department, internal, country, and investigator file reviews
- Provide administrative support for site activation and help develop site activation critical paths
- Develop and review site lists for feasibility activities and contribute local input to site tiering
- Coordinate, oversee, and complete assigned trial activities according to the task matrix
- Document findings in appropriate systems and proactively communicate project risks
- Provide support for Activate and eTMF systems and maintain current databases
- Process and review eTMF documents, distribute mailings and communications, and provide reports to internal teams
- Analyze and reconcile study metrics and findings reports
- Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support study-specific translation materials and translation quality control
- Support client/internal meeting scheduling and local regulatory document tracking
- Support RBM activities and study-specific documentation, training tracking, system access, and activity plans
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers and support regulatory submissions
- Work with sites to obtain site-selection documents and support regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities with the activation critical path
- Complete Site Interest Plans in CTMS and collect associated investigator/site personnel documents when applicable
- 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 to meet project deadlines and address site issues and risks
- Maintain site contact and follow-up plans and escalate non-compliance concerns
- Act as a local expert on site capacity and experience, recommend additional sites, and support local site tiering
- 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
- Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year)
- Bachelor's degree preferred
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail; ability to handle multiple tasks efficiently and effectively
- Ability to analyze project-specific data/systems for accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload according to changing project timelines
- Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and 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) and ability to learn clinical trial database systems
- Ability to complete the organization's clinical training program
- Effective oral and written communication, interpersonal, judgment, decision-making, negotiation, risk-management, and work-instruction-following skills
- High self-motivation and positive attitude
- Occasional travel and drives to site locations may be required
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule