Clinical Trial Coordinator – FSP

🔥 1 minute ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• Coordinate, oversee, and complete assigned clinical trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Ensure allocated tasks are completed on time, within budget, and to a high-quality standard • Process documents in the client (e)TMF, perform (e)TMF reviews, distribute communications, and provide documents and reports • Review and track local regulatory documents • Analyze and reconcile study metrics and findings reports • Maintain vendor trackers and study status information in databases • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Provide technical and administrative project support with internal departments and team members • Train new personnel and support process improvements • Maintain study documentation, team lists, training requirements, system access, and activity plans • Support Activate, eTMF, RBM, regulatory submissions, IRB/IEC document transmission, meetings, and meeting minutes • Coordinate site start-up activities and regulatory compliance review packages • Obtain site-selection documents and develop site lists using internal and external sources • Maintain investigator and site staff contact details and document site communications in CTMS • Review survey data and follow up with sites to meet project deadlines • Conduct feasibility interviews and contribute to global feasibility processes and best practices • Provide finance support, including raising and amending POs, creating vendors, cross-charging, finance queries, budget tracking/reporting/forecasting, Veeva Payments, and invoicing support

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Strong organizational skills and attention to detail, with ability to handle multiple tasks efficiently • Ability to analyze project-specific data/systems for accuracy and efficiency • Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office (Word, Excel, PowerPoint) and ability to learn clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills, including communication with medical personnel • Basic medical/therapeutic area and medical terminology knowledge • Basic knowledge of local health systems • Working knowledge of GCP and applicable SOPs • Ability to work in a matrix environment and manage risk appropriately • Systems knowledge or ability to learn CERPS, Ariba, Fiori, and Veeva Payments

🏖️ Benefits

• Fully Remote work arrangement • Standard Monday-Friday work schedule

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