Clinical Trial Coordinator

🔥 1 minute ago

🇧🇷 Brazil – 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 file reviews according to SOPs and department guidance • Support site activation activities and development of 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 • Perform department, internal, country and investigator file reviews and document findings • Complete allocated tasks on time, within budget and to quality standards; communicate risks to project leads • Provide system support for Activate and eTMF and keep databases current • Process documents to the 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 and 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 and tracking of local regulatory documents • Support risk-based monitoring activities and study documentation/system maintenance • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers and 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 with the activation critical path • 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 regarding site issues and risks • Maintain plans for site contact and follow-up and escalate 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 • 0 to 1 year of comparable experience • 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 • 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, PowerPoint) • Ability to learn and master clinical trial database systems • Ability to complete the organization's clinical training program • Effective oral and written communication skills • Judgment and decision-making skills • Ability to follow project work instructions accurately • Negotiation skills • Ability to manage risk and escalate risks 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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