Clinical Trial Coordinator

🔥 24 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 24 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 organizational SOPs and department guidance • Provide administrative support for site activation activities • Aid development of the site activation critical path to support rapid site activations • Develop and review site lists using local knowledge, organization systems, external site lists and sponsor directives • Provide local input into site tiering for feasibility activities • Coordinate, oversee and complete assigned trial activities according to the task matrix • Perform department, internal, country and investigator file reviews and document findings in appropriate systems • Ensure allocated tasks are completed on time, within budget and to a high-quality standard; communicate risks to project leads • Support and maintain Activate, eTMF and other clinical trial systems and databases • Process documents for client eTMF, perform eTMF reviews, distribute communications and provide reports to internal team members • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings • Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Schedule client and internal meetings as needed • Review and track local regulatory documents • Support risk-based monitoring activities and study-specific documentation, training requirements, system access and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection documentation • Assist with regulatory compliance review packages and coordinate with internal departments on site start-up activities • Complete Site Interest Plans in CTMS and collect associated investigator and site personnel 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 to meet deadlines and address site issues and risks • Maintain efficient site contact and follow-up plans, escalating concerns and non-compliance to management • Act as a local expert on site capacity and experience; identify and develop new sites and support local site tiering • Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information • Contribute to global strategic feasibility processes and best practices • Train new personnel in processes and systems • May conduct on-site feasibility visits in Asia Pacific

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • 0 to 1 year of previous experience providing relevant knowledge, skills, and abilities • Combination of appropriate education, training and/or directly related experience may be considered equivalent • 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 with a positive attitude and good interpersonal skills • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Independent thinking • Ability to manage risk and perform appropriate risk escalation • Occasional drives to site locations and potential occasional travel required

🏖️ Benefits

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

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