FSP Clinical Trial Coordinator I

🔥 11 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 department, internal, country and investigator file reviews • 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 • Document file-review findings in appropriate systems • Complete allocated tasks on time, within budget and to quality standards, escalating risks to project leads • Provide system support for Activate and eTMF 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 resolution of site-documentation findings • Coordinate and distribute Investigator Site File, Pharmacy binder materials and study supplies • Support translation materials and translation quality control • Maintain knowledge of SOPs, client directives and regulatory guidelines • Support client/internal meeting scheduling, local regulatory-document tracking and RBM activities as applicable • Maintain study documentation and systems, including team lists, training requirements, system access and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Work directly with sites to obtain site-selection documents • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities • Complete Site Interest Plans in CTMS and collect associated investigator/site documents • Document site communications, follow-ups and survey responses in real time • Review survey data for logical, complete and relevant responses • Collaborate with teammates and clinical personnel on deadlines, site issues and risks • Ensure site-contact plans are followed and escalate concerns or non-compliance • Contribute local expertise to site-capacity assessment, site recommendations and site tiering • 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 in processes and systems • Use 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 • Previous experience comparable to 0 to 1 year • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Ability to work independently or in a team • 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 • Working knowledge of applicable country regulations, ICH Good Clinical Practices, 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 • Self-motivated, positive attitude and good interpersonal skills • 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 perform risk escalation appropriately

🏖️ Benefits

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

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