Clinical Operations Specialist
2 weeks ago
At Thermo Fisher Scientific, you will be part of a team dedicated to improving health. Our clinical research group is responsible for enabling our customers to make the world healthier, cleaner and safer.
About the Role:- Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
- Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
- Provides system support (GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks including timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling of client and/or internal meetings with completion of related meeting minutes.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
- Ability to work in a team or independently as required.
- Ability to handle multiple tasks efficiently.
- Ability to analyze project-specific data/systems to ensure accuracy and efficiency.
- With flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines.
- Ability to attain and maintain a good understanding of applicable Country Regulations, ICH and organization/Client SOPs and WPDs and closeout.
- Strong English language and grammar skills and proficient local language skills as needed.
- Strong IT skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
- Ability to complete CRG clinical training program.
We are committed to providing a supportive and inclusive work environment. If you are passionate about making a difference in the lives of others, we encourage you to apply for this exciting opportunity to join our team at Thermo Fisher Scientific.
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