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Clinical Trial Coordinator
Thermo Fisher Scientific. Provide administrative and technical support to project teams as a study lead and cross-functional liaison .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in project coordination, regulatory compliance, and clinical trial management, with a strong focus on training, documentation, and stakeholder communication. Proficient in analyzing project data and maintaining quality standards while supporting cross-functional teams.
Highest-signal resume keywords
Project CoordinationRegulatory ComplianceClinical Trial ManagementTraining and DevelopmentData 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
Clinical Trial Database SystemsProject-Specific Data AnalysisRisk ManagementETMF ReviewsSite ActivationRegulatory SubmissionsDocument ProcessingFeasibility AssessmentBudget ManagementQuality Control
Soft Skills
Organizational SkillsAttention to DetailInterpersonal CommunicationProblem-SolvingNegotiation Skills
Tools & Technologies
MS OfficeCTMSETMF Systems
Industry Keywords
ICH Good Clinical PracticesSOPsWPDsLocal Health SystemsMedical Terminology
About the role
Key responsibilities & impact- Provide administrative and technical support to project teams as a study lead and cross-functional liaison
- Coordinate and facilitate project activities and oversee administration on assigned projects
- Act as a buddy during onboarding and train new staff
- Identify training requirements and support departmental and cross-functional process improvement initiatives
- Develop critical paths for site activation and serve as a point of escalation for project teams
- Coordinate, oversee and complete assigned trial activities according to task matrices
- Perform department, internal, country and investigator file reviews and document findings
- Ensure allocated tasks are completed on time, within budget and to quality standards
- Maintain study documentation, systems, tools, trackers, study team lists, training requirements, access management and activity plans
- Support risk-based monitoring activities
- Process documents, perform eTMF reviews, distribute communications and provide reports
- Schedule and organize client/internal meetings and complete meeting minutes
- Review and track local regulatory documents and support audit readiness and audit responses
- Transmit documents to clients and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports
- Maintain vendor trackers and current study databases
- Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support translation materials and translation quality control
- Liaise locally on regulatory submissions in accordance with global strategy
- Maintain accurate trial status information
- Conduct on-site feasibility visits where applicable in Asia Pacific
- Provide training to functional team members, investigators and clients
- Serve as an alliance-level lead for client integration and eTMF activities
- Support site activation, site agreements, budgets, essential documents and regulatory compliance packages
- Develop site lists, maintain investigator/site contact details and complete Site Interest Plans in CTMS
- Coordinate site contact, follow-up, survey data review and response goals
- Act as local expert on site capacity and experience and recommend additional sites
- Conduct phone interviews with physicians and site personnel regarding standard of care and protocol input
- Resolve investigator queries and maintain account/contact information
- Contribute to global feasibility processes, best practices and new-site identification
- Serve as subject matter expert on feasibility survey tools and future system releases
Requirements
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Bachelor's degree preferred
- At least 6 years of previous experience providing the knowledge, skills, and abilities to perform the job
- Equivalent combination of appropriate education, training and/or directly related experience may be considered
- Ability to work independently or in a team
- Excellent organizational skills and attention to detail
- Ability to analyze project-specific data and systems
- Flexibility and adaptability to changing project timelines
- Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
- Excellent English language and grammar skills and proficient local language skills as needed
- Effective presentation skills
- Proficiency in MS Office (Word, Excel, PowerPoint) and ability to master clinical trial database systems
- Ability to successfully complete the organization's clinical training program
- Strong interpersonal, oral and written communication, problem-solving, negotiation and customer-focus skills
- Basic medical/therapeutic area and medical terminology knowledge
- Basic knowledge of local health systems
- Ability to work in a matrix environment
- Ability to manage risk and perform risk escalation appropriately
Benefits
Comp & perks- Fully remote work mode
- Standard Monday–Friday work schedule
- Potential occasional travel
- Clinical training program
- Training and onboarding support