Clinical Trial Coordinator I

🔥 2 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 2 hours ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled file reviews according to SOPs and department guidance • Provide administrative support for site activation and help develop site-activation critical paths • Develop and review site lists for feasibility activities and provide local input into site tiering • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads • Support Activate and eTMF systems and keep databases current • Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide reports • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Assist with translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Support client/internal meeting scheduling, regulatory document tracking, RBM activities, study documentation, training tracking, system access, and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Work with sites to obtain site-selection documents and prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities with the activation critical path • Complete Site Interest Plans, collect investigator/site documents, document site communications, and review survey data • Collaborate with teammates and clinical personnel on deadlines, site issues, risks, contact plans, and escalations • Act as a local expert on site capacity and experience; recommend and tier sites using local knowledge • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global feasibility processes and best practices • Train new personnel and utilize local knowledge to identify and develop new sites

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 0 to 1 year • Bachelor's degree preferred • Ability to work in a team or independently • Good organizational skills and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload according to changing project timelines • 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 • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to complete the organization's clinical training program • Effective oral and written communication skills • Judgment and decision-making skills • Ability to follow project work instructions accurately • Good negotiation skills • Ability to manage risk and perform appropriate risk escalation • Occasional travel and drives to site locations may be required

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday schedule

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