Clinical Trial Coordinator

🔥 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

• 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 a high-quality standard • Communicate project risks proactively to project leads • Provide support for Activate, eTMF and other clinical trial systems and keep databases current • Process documents for the client eTMF, perform eTMF reviews, distribute mailings and communications, and provide documents and reports to internal teams • Analyze and reconcile study metrics and findings reports • Assist with resolution of site-documentation findings • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support translation materials and translation quality control • Follow applicable 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 • Support regulatory submissions and prepare regulatory compliance review packages • Obtain site-selection documents directly from sites • Coordinate with internal departments to align site start-up activities with the site activation critical path • Complete Site Interest Plans and collect associated investigator/site documents as applicable • 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 to meet deadlines and address site issues and risks • Establish and monitor site-contact and follow-up plans, escalating concerns and non-compliance to management • Provide local expertise 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 • 0 to 1 year of previous comparable experience • 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 manage 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, organization/client SOPs and WPDs • Good English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office, including Word, Excel and PowerPoint • Ability to learn and master clinical trial database systems • Ability to successfully 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 • Good negotiation skills • Independent thinking • Ability to manage risk and perform risk escalation appropriately • Occasional driving to site locations; potential occasional travel required

🏖️ Benefits

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

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