Thermo Fisher Scientific is looking for a Clinical Trial Coordinator (FSP) to join our global team in Kenya. In this role, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.
Key Responsibilities
Trial Coordination: According to the specific role (Central or Local), coordinates, oversees, and completes functions on assigned trials activities detailed on the task matrix.
File Reviews: Performs department, Internal, Country, and Investigator file reviews as assigned and documents findings in appropriate system.
Task Management: Ensures allocated tasks are performed on time, within budget, and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Documentation & Global Support: Supports the maintenance of study-specific documentation and global support with specific systems, tools, and trackers (including but not limited to: study team lists, tracking of project-specific training requirements, system access management, and tracking of project-level activity plans). Ensures (e)TMF is up to date by following file review schedules.
System & Administrative Support: Provides system support (i.e. GoBalto & eTMF) and supports Risk-Based Monitoring (RBM) activities. Performs administrative tasks on assigned trials such as timely processing of documents, performing mass mailings/communications, and compiling reports.
Meetings & Logistics: Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Regulatory Tracking: Reviews and tracks local regulatory documents and transmits documents to client and centralized IRB/IEC.
Metrics Analysis: Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Supplies & Vendors: 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.
Translations & Other Duties: Assists with study-specific translation materials and translation Quality Control (QC) upon request. May attend Kick-off meetings and take notes as required.
Requirements and Qualifications
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree is highly preferred.
At least four (4) years of previous experience providing the knowledge, skills, and abilities to perform the job. (An equivalent combination of education, training, and/or directly related experience may be considered).
Strong organizational skills, attention to detail, and ability to handle multiple tasks efficiently.
Demonstrated flexibility and adaptability to changing project timelines.
Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs.
Excellent English language, grammar, and computer skills (MS Office - Word, Excel, PowerPoint).
Ability to successfully complete PPD clinical training program.
How to Apply
Interested and qualified candidates should apply online by visiting the official application link:
