Clinical Trial Coordinator

🔥 10 minutes ago

🇨🇴 Colombia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Clinical Trial Coordinator

🚫👨‍🎓 No degree required

👻 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

• Assist in coordinating and administering clinical studies from start-up through execution and close-out • Collect, prepare, review, track, and submit study documents to EC/IRB and regulatory authorities • Interface with investigators, external service providers, CRAs, Data Management, and Global Clinical Solutions representatives • Serve as the local administrative main contact and work with CRAs and/or LSAD throughout the study • Set up and maintain the local eTMF and ISF in accordance with ICH-GCP and local requirements • Upload essential documents promptly to maintain eTMF inspection readiness • Prepare documents for final archiving and support ISF close-out activities • Produce and maintain study documents, ensuring template and version compliance • Create or import clinical-regulatory documents into the Global Electronic Management System • Support electronic applications and submissions using Submission Ready Standards • Set up and maintain information in CTMS, SharePoint, and other tracking and communication tools • Prepare or support site-level contracts and HCO/HCP payments • Coordinate and track study materials and equipment • Coordinate administrative tasks during studies, audits, and regulatory inspections • Lead practical arrangements and support preparation of internal and external meetings • Prepare and distribute presentation materials, newsletters, websites, letters, and meeting minutes • Perform layout and language control, copying, document distribution, translation, spell checks, and email archiving • Ensure compliance with company ethics, policies, procedures, legislation, and safety requirements

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable +2 years) • 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 for changing project timelines • Working 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 successfully complete the organization's clinical training program • Self-motivated, 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 risk escalation appropriately • Occasional drives to site locations

🏖️ Benefits

• Potential occasional travel required • Clinical training program • Remote work arrangement • Standard Monday–Friday work schedule

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