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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 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 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 to project leads
- Support Activate and eTMF systems and keep databases current
- Process documents sent to client eTMF, perform eTMF reviews, distribute communications and provide reports
- Analyze and reconcile study metrics and findings reports
- Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Assist with 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 RBM activities and study-specific documentation and systems
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions and site start-up activities
- Work directly with sites to obtain site-selection documents
- Prepare regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities with the activation critical path
- Complete Site Interest Plans and collect associated investigator/site documents where applicable
- 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 efficient site contact and follow-up plans and escalate non-compliance
- Act as a local expert 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
- Appropriate education, training and/or directly related experience may be considered as an equivalency
- 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
- 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 risk escalation appropriately
- Occasional drives to site locations and potential occasional travel
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule