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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 activities and contribute to 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 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 quality standards; communicate risks to project leads
- Provide system support for Activate and eTMF and maintain current databases
- Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
- Analyze and reconcile study metrics and findings reports
- 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 regulatory guidelines
- Support client and internal meeting scheduling
- Review and track local regulatory documents
- Support RBM activities and study-specific documentation and systems
- Transmit documents to the client and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions and site selection document collection
- Prepare regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities with the site activation critical path
- Complete Site Interest Plans in CTMS and collect associated investigator/site personnel 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 site issues and risks
- Maintain 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
- 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
- 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 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, 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
- Self-motivated, positive attitude, and good interpersonal skills
- Effective oral and written communication skills
- Essential judgment and decision-making skills
- Ability to accurately follow project work instructions
- Good negotiation skills
- Independent thinking
- Ability to manage risk and perform appropriate risk escalation
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday-Friday work schedule
- Potential occasional travel
- Training provided for new personnel and clinical training program