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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 proficiency in coordinating clinical trial activities, ensuring compliance with regulatory guidelines, and managing documentation and communication effectively. Capable of analyzing study metrics and providing system support for clinical trial databases.
Highest-signal resume keywords
Clinical Trial CoordinationRegulatory Compliance KnowledgeMS Office ProficiencyRisk ManagementSite Activation Support
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 SystemsDocument ReviewStudy Metrics AnalysisSOP KnowledgeTranslation Quality Control
Soft Skills
Communication SkillsTeam CollaborationProblem-Solving
Tools & Technologies
ActivateETMFCTMS
Industry Keywords
ICH Good Clinical PracticesCountry RegulationsClient SOPsInvestigator Site FilePharmacy Binder Materials
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
- Provide system support for Activate and eTMF and keep databases current
- Process and review trial documents, distribute communications, and provide reports to internal team members
- Analyze and reconcile study metrics and findings reports
- Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support study-specific translation materials and translation quality control
- Maintain knowledge of SOPs, client directives, and regulatory guidelines
- Support meeting scheduling, local regulatory document tracking, RBM activities, documentation, access management, and activity plans
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers and support regulatory submissions
- Work directly with sites to obtain site-selection documents
- Assist with regulatory compliance review packages and site activation activities
- Complete Site Interest Plans in CTMS and collect associated investigator/site documents when applicable
- Document site communications, follow-ups, and survey responses in real time
- Review survey data for logical, complete, and accurate responses
- Collaborate with teammates and clinical personnel to meet deadlines and manage site issues and risks
- Develop and enforce site contact and follow-up plans, escalating concerns or non-compliance
- Provide local expertise on site capacity, experience, tiering, and identification of new sites
- Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
- Contribute to global feasibility processes and best practices
- Train new personnel in processes and systems
Requirements
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 0 to 1 year
- Bachelor's degree preferred
- Good English language and grammar skills and proficient local language skills as needed
- Proficient in MS Office (Word, Excel, and PowerPoint)
- Ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete the organization's clinical training program
- Knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
- Ability to accurately follow project work instructions
- Ability to manage risk and perform risk escalation appropriately
- Occasional drives to site locations and potential occasional travel required
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule
- Potential occasional travel
- Training provided for new personnel and clinical training program