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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 maintaining high-quality standards in documentation and reporting. Possesses strong organizational skills and the ability to analyze project-specific data effectively.
Highest-signal resume keywords
Clinical Trial CoordinationRegulatory Compliance KnowledgeData Analysis SkillsMS Office ProficiencyEffective 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 SystemsDocument Review and ProcessingSite Selection DocumentationStudy Metrics AnalysisTranslation Quality Control
Soft Skills
Attention to DetailCustomer FocusTeam CollaborationNegotiation SkillsDecision-Making Skills
Tools & Technologies
ETMFCTMSMS Office
Industry Keywords
ICH Good Clinical PracticesSOPsRegulatory GuidelinesFeasibility StudiesSite Start-Up Activities
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 support for Activate, eTMF and other clinical trial systems; maintain current databases
- Process documents for the Client (e)TMF, perform (e)TMF reviews, distribute communications and provide reports
- Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings
- Coordinate 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 applicable regulatory guidelines
- Conduct on-site feasibility visits where applicable in Asia Pacific
- Support client/internal meeting scheduling and tracking of local regulatory documents
- Support RBM activities and study-specific documentation, training requirements, system access and activity plans
- Transmit documents to the client and centralized IRB/IEC
- Maintain vendor trackers and support regulatory submissions
- Work directly with sites to obtain site-selection documents
- Prepare regulatory compliance review packages with the project team
- Coordinate with internal departments to align site start-up activities with the activation critical path
- Complete Site Interest Plans in CTMS and collect associated documents when applicable
- Document 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 deadlines, site issues and risks
- Maintain site-contact and follow-up plans; escalate concerns and 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 providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year
- Equivalency through a combination 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 analyze project-specific data/systems accurately and efficiently
- Strong customer focus and 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, PowerPoint)
- Ability to learn and master clinical trial database systems
- Ability to complete the organization's clinical training program
- Effective oral and written communication, interpersonal, negotiation, judgment, decision-making, risk management and escalation skills
- Ability to accurately follow project work instructions
Benefits
Comp & perks- Fully Remote work arrangement
- Standard Monday–Friday work schedule
- Potential occasional travel
- Training and onboarding support
- Opportunity to act as a buddy and train new staff