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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 documentation. Capable of analyzing study metrics and effectively communicating with stakeholders while managing project timelines and risks.
Highest-signal resume keywords
Clinical Trial CoordinationRegulatory ComplianceData AnalysisMS Office ProficiencyGood Clinical Practices
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 ReviewProject ManagementRisk ManagementTranslation Quality Control
Soft Skills
Attention to DetailOrganizational SkillsCustomer FocusEffective CommunicationNegotiation Skills
Tools & Technologies
ActivateETMFCTMS
Industry Keywords
SOPsICH Good Clinical PracticesRegulatory SubmissionsSite SelectionFeasibility Studies
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 system databases current
- Process documents for Client (e)TMF, perform (e)TMF reviews, distribute communications and provide reports
- Analyze and reconcile study metrics and findings reports
- Assist with Investigator Site File and Pharmacy binder materials and study supplies
- Assist with study-specific translation materials and translation quality control
- Maintain knowledge of SOPs, client directives and regulatory guidelines
- Conduct on-site feasibility visits where applicable for Asia Pacific roles
- Support client and internal meeting scheduling
- Review and track local regulatory documents
- Support risk-based monitoring activities
- Maintain study documentation, team lists, training requirements, system access and activity plans
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions and site start-up activities
- Obtain site-selection documents directly from sites
- Prepare regulatory compliance review packages
- 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 deadlines, site issues and risks
- Ensure effective 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 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
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- Ability to work in a team or independently
- Good organizational skills and strong attention to detail
- Ability to analyze project-specific data/systems accurately and efficiently
- Strong customer focus
- Flexibility to reprioritize workload
- 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)
- Ability to learn and master clinical trial database systems
- Ability to successfully 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 risk escalation appropriately
- Occasional travel may be required
- Occasional drives to site locations
Benefits
Comp & perks- Fully Remote work arrangement
- Standard Monday–Friday work schedule