Clinical Trial Coordinator

🔥 17 minutes 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 17 minutes 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 by reviewing files according to SOP schedules and department guidance • Provide administrative support for site activation activities • Aid development of the site activation critical path • Develop and review site lists for feasibility activities and provide local input into site tiering • Act as a buddy during onboarding and train new staff as needed • Coordinate, oversee, and complete assigned 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 quality standards • Provide system support for Activate and eTMF and keep databases current • Process documents to client eTMF, perform eTMF reviews, distribute mailings and communications, and provide reports • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials and study supplies • Support translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Conduct on-site feasibility visits where applicable • Support client and internal meeting scheduling • Review and track local regulatory documents • Support risk-based monitoring activities • 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 • Support regulatory submissions • Obtain site-selection documents directly from sites • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities • Complete Site Interest Plans in CTMS and collect associated documents • Document communications, follow-ups, and survey responses in real time • Review survey data for logical, complete, and relevant responses • Collaborate with teammates to meet project deadlines • Communicate site issues and risks to clinical personnel • Maintain plans for site contact and follow-up and escalate concerns or non-compliance • 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 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 accepted • 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 • 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 • Self-motivated with a positive attitude and good interpersonal skills • Effective oral and written communication skills • Judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Independent thinking • Ability to manage risk and perform risk escalation appropriately • Occasional drives to site locations and potential occasional travel

🏖️ Benefits

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

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