Clinical Trial Coordinator I

🔥 12 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 activities and help develop site activation critical paths • Develop and review site lists for feasibility activities and contribute local input to 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 • Maintain and support Activate, eTMF, CTMS, and other clinical trial systems and databases • Process and review eTMF documents, distribute communications, and provide documents and reports to internal teams • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials, study supplies, translations, and translation QC • Support meetings, regulatory document tracking, RBM activities, study documentation, training tracking, and system access management • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Work directly with sites to obtain site-selection documents and coordinate site start-up activities • Prepare regulatory compliance review packages • Complete Site Interest Plans, collect investigator/site documents, and document site communications and follow-up • Review survey data for logical and complete responses • Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and escalation • Act as a local expert on site capacity and experience and recommend additional sites • 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 support onboarding • Utilize local knowledge to identify and develop new sites

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Comparable previous experience of 0 to 1 year • 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 successfully complete the organization's clinical training program • Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs • Ability to follow project work instructions accurately • Ability to manage risk and perform risk escalation appropriately • Occasional drives to site locations; potential occasional travel required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Potential occasional travel • Clinical training program

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