Clinical Trial Coordinator I

🔥 2 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 Ghost score 12%

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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 department, internal, country, investigator, and eTMF file reviews • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Support site activation activities and development of site activation critical paths • Develop and review site lists for feasibility activities and contribute local input to site tiering • Ensure allocated tasks are completed on time, within budget, and to quality standards • Provide system support for Activate and eTMF and keep databases current • Process and transmit documents to client eTMF and centralized IRB/IEC • Distribute mass mailings, communications, documents, reports, ISF, pharmacy binder materials, and non-clinical study supplies • Analyze and reconcile study metrics and findings reports • Assist with resolution of site documentation findings • Support study-specific translation materials and translation quality control • Maintain study documentation, team lists, training requirements, system access, activity plans, vendor trackers, and regulatory documents • Support regulatory submissions and preparation of regulatory compliance review packages • Work with sites to obtain site-selection documents and coordinate site contact and follow-up • Review survey data for logical, complete, and accurate responses • Communicate site issues and risks to clinical personnel and escalate concerns or non-compliance • Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information • Contribute to global feasibility processes and best practices • Train new personnel and act as a buddy during onboarding • 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 • 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 work independently or as part of a team • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently • Ability to analyze project-specific data and systems • Flexibility to reprioritize workload according to changing timelines • Effective oral and written communication skills • Judgment and decision-making skills • Ability to accurately follow project work instructions • Negotiation skills • Ability to manage risk and escalate appropriately • Occasional travel and drives to site locations may be required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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