Clinical Trial Coordinator

🔥 45 minutes ago

🇧🇷 Brazil – 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 45 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 • Assist in developing the site activation critical path • Develop and review site lists for feasibility activities and provide local input into site tiering • 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 maintain current databases • Process documents for Client eTMF, perform eTMF reviews, distribute communications and provide reports • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials and study supplies • Assist with translation materials and translation quality control • Maintain knowledge of SOPs, client directives and regulatory guidelines • Support client/internal meeting scheduling and local regulatory document tracking • Support RBM activities and study documentation/system maintenance • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection document collection • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities • Document site communications, follow-ups and survey responses in real time • Review survey data for completeness and logical consistency • Communicate site issues and risks and escalate concerns or non-compliance • Act as 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 • Identify and develop new sites using local knowledge

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • 0 to 1 year of comparable experience • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Ability to work independently or in a team • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently and effectively • Ability to analyze project-specific data and systems accurately • 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, including Word, Excel and PowerPoint • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • 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 drives to site locations and potential occasional travel

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Potential occasional travel • Clinical training program

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