Thermo Fisher Scientific
10,000+ employees
Founded 1956
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Clinical Trial Coordinator I – FSP
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Thermo Fisher Scientific
10,000+ employees
Founded 1956
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
📋 Description
• Assists in coordination and administration of clinical studies from the start-up to execution and close-out • Collects, assists in preparation, reviews and tracks documents for the application process • Interfaces with Investigators, external service providers and CRAs to support effective delivery of a study and its documents • Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study • Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF • Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness" • Ensures that all study documents are ready for final archiving and completion of local part of the eTMF • Contributes to the production and maintenance of study documents • Creates and/or imports clinical-regulatory documents into the Global Electronic Management System • Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards • Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools • Prepares and/or supports contract preparation at a site level • Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations • Manages and contributes to coordination and tracking of study materials and equipment • Coordinates administrative tasks during the study process, audits and regulatory inspections • Responsible for layout and language control, copying and distribution of documents • Responsible for printing and distribution of documents such as letters and meeting minutes • Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material • Ensures compliance with client's Code of Ethics and company policies and procedures
🎯 Requirements
• High / Secondary school diploma or equivalent • Bachelor's degree preferred • 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, and organization/Client SOPs and WPDs • Good English language and grammar skills and proficient local language skills as needed • Good computer skills and proficient in MS Office (Word, Excel, and PowerPoint) • Ability to successfully complete the organization's clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Good negotiation skills • Capable of accurately following project work instructions
🏖️ Benefits
• Health insurance • 401(k) matching
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