Clinical Trial Coordinator
Employer · ThermoFisher Scientific
Budapest
As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed according to the schedule and provide administrative support for site activation activities.
Tasks
- Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
- Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
- Performs administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF, distributing mass mailings and communications.
- Analyzes and reconciles study metrics and findings reports.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials.
- Maintains vendor trackers and supports start-up team in Regulatory submissions.
- Trains new personnel in processes and systems.
Requirements
- Life Science degree
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year)
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail
- Demonstrated ability to effectively analyze project-specific data/systems
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices