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Clinical Trial Coordinator
Thermo Fisher Scientific. Provide administrative and technical support to the Project Team .
About the role
Key responsibilities & impact- Provide administrative and technical support to the Project Team
- Support audit readiness through scheduled file reviews
- Provide administrative support for site activation activities
- Aid development of site activation critical paths
- Develop and review site lists for feasibility activities and contribute to local site tiering
- Coordinate, oversee and complete assigned trial activities according to the task matrix
- Perform department, internal, country and investigator file reviews and document findings
- Complete allocated tasks on time, within budget and to quality standards; communicate risks
- Support Activate and eTMF systems and keep databases current
- Process and review eTMF documents, distribute communications and provide reports
- Analyze and reconcile study metrics and findings reports
- Coordinate Investigator Site File and Pharmacy binder materials and non-clinical supplies
- Support study-specific translation materials and translation quality control
- Maintain knowledge of SOPs, client directives and regulatory guidelines
- Support client/internal meeting scheduling and local regulatory document tracking
- Support RBM activities and study documentation/system maintenance
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers and support regulatory submissions
- Obtain site-selection documents directly from sites
- Prepare regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities
- Complete Site Interest Plans and collect associated investigator/site documents
- Document site communications, follow-ups and survey responses in real time
- Review survey data for logical and complete responses
- Collaborate with teammates and clinical personnel regarding site issues and risks
- Maintain site contact and follow-up plans and escalate 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 contact information
- Contribute to global feasibility processes and best practices
- Train new personnel in processes and systems
- Utilize 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
- Equivalent 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 handle multiple tasks efficiently and effectively
- Ability to analyze project-specific data/systems for accuracy and efficiency
- Strong customer focus
- 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
- Proficient in MS Office (Word, Excel and PowerPoint)
- Ability to learn and master clinical trial database systems
- Ability to complete the organization's clinical training program
- Effective oral and written communication skills
- Judgment and decision-making skills
- Ability to follow project work instructions accurately
- Good negotiation skills
- Ability to manage risk and perform risk escalation appropriately
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule