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FSP 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 according to SOPs and department guidance
- Provide administrative support for site activation and help develop site activation critical paths
- Develop and review site lists for feasibility activities and contribute local input to site tiering
- Coordinate, oversee, and complete assigned trial activities according to task matrices
- Perform department, internal, country, and investigator file reviews and document findings
- Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads
- Maintain Activate, eTMF, and other study systems and databases
- Process and review eTMF documents, distribute communications, and provide documents and reports
- Analyze and reconcile study metrics and findings reports
- Coordinate and distribute Investigator Site File, pharmacy binder materials, and study supplies
- Support translation materials and translation quality control
- Support client/internal meeting scheduling and local regulatory document tracking
- Support RBM activities and study documentation, training, access, and activity-plan tracking
- 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 in CTMS and collect associated investigator/site documents
- 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 on deadlines, site issues, and risks
- Maintain efficient 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 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
- Where applicable, conduct on-site feasibility visits in Asia Pacific
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
- 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
- Judgment and decision-making skills
- Ability to follow project work instructions accurately
- Negotiation skills
- Ability to manage risk and perform risk escalation appropriately
- Occasional travel and drives to site locations may be required
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule