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Clinical Trial Coordinator – FSP
Location
Kenya
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Clinical Trial Coordinator – FSP
Thermo Fisher Scientific
• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. • 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. • 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 for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. • Provides system support (i.e. GoBalto & eTMF). • Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: 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 and organization 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. • May attend Kick off meeting and take notes when required.
Job Requirements
- 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 at least 4 years).
- Ability to work in a team or independently as required
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support 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
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation skills
- Excellent 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 with effective strong interpersonal skills.
Benefits
- Paid time off
- Flexible working arrangements
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• Join as a Clinical Trial Coordinator and provide administrative and technical support to the Project Team. • Support audit readiness by ensuring files are reviewed according to the schedule. • Provide administrative support for site activation activities. • Develop collaborative relationships with investigators and site personnel. • Analyze and reconcile study metrics and findings reports. • Maintain vendor trackers and assist with study-specific materials.
• Provide administrative and technical support to the Project Team • Assist with audit readiness and site activation activities • Develop collaborative relationships with investigators and site personnel
• Coordinates, oversees and completes functions on assigned trial(s) activities • Ensures allocated tasks are performed on time, within budget and to a high-quality standard • Proactively communicates any risks to project leads • Provides system support and ensures system databases are current • Performs administrative tasks on assigned trials • Analyzes and reconciles study metrics and findings reports • Supports start-up team in regulatory submissions • Collaborates with teammates to achieve targeted deadlines
• Coordinate, oversee and complete functions on assigned trials activities detailed on the task matrix • Perform department, Internal, Country and Investigator file reviews as assigned and document findings in appropriate system • Ensure allocated tasks are performed on time, within budget and to a high quality standard • Proactively communicate any risks to project leads and line manager as appropriate • Support the maintenance of study specific documentation and global support with specific systems, tools and trackers • Provide system support (i.e. GoBalto & eTMF) • Support RBM activities • Perform administrative tasks on assigned trials including timely processing of documents sent to Client (e)TMF as assigned • Support scheduling and organization of client and/or internal meetings with completion of related meeting minutes • Review and track local regulatory documents • Transmit documents to client and centralized IRB/IEC • Analyze and reconcile study metrics and findings reports
