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Clinical Trial Operations Coordinator
hace 2 meses
We are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team at Thermo Fisher Scientific. As a Clinical Trial Coordinator, you will play a critical role in supporting the planning, execution, and closeout of clinical trials.
Key Responsibilities- Provide administrative and technical support to the Project Team, ensuring timely completion of tasks and adherence to project timelines.
- Support audit readiness by reviewing files and ensuring compliance with organizational and departmental guidelines.
- Coordinate and oversee trial activities, including department, internal, country, and investigator file reviews.
- Ensure allocated tasks are performed on time, within budget, and to a high-quality standard.
- Proactively communicate any risks or issues to project leads.
- Support the maintenance of study-specific documentation and systems, including tracking of project-specific training requirements and system access management.
- Provide system support, including GoBalto and eTMF.
- Support Risk-Based Monitoring (RBM) activities.
- Perform administrative tasks, including timely processing of documents, performing eTMF reviews, and providing documents and reports to internal team members.
- Support scheduling of client and/or internal meetings.
- Review and track local regulatory documents.
- Transmit documents to client and centralized IRB/IEC.
- Analyze and reconcile study metrics and findings reports.
- Assist with clarification and resolution of findings related to site documentation.
- Maintain vendor trackers.
- Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assist with study-specific translation materials and translation QC upon request.
- High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
- In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Ability to work in a team or independently as required.
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
- 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, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.
- Good English language and grammar skills and proficient local language skills as needed.
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
- Ability to successfully complete PPD clinical training program.
- Self-motivated, positive attitude, and good interpersonal skills.
