Clinical Trial Coordinator

🔥 2 minutes ago

🇵🇪 Peru – 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

• Coordinate and administer clinical studies from start-up through execution and close-out • Collect, prepare, review and track documents for ethics committee/IRB and regulatory submissions • Interface with investigators, external service providers and CRAs during document collection • Serve as the local administrative main contact and work closely with CRAs and/or LSAD • 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 CRA close-out activities for the ISF • Produce and maintain study documents in compliance with templates and version requirements • Create/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/communication tools • Prepare or support site-level contract preparation • Prepare, support or perform HCO/HCP payments in accordance with local regulations • 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 • Liaise with meeting participants and vendors in accordance with international and local codes • Prepare, contribute to and distribute presentation materials, newsletters and website content • Perform layout and language control, copying and document distribution • Support local translation and spell checks between English and the local language • Print and distribute letters and meeting minutes and handle/archive study-related emails • Interface with Data Management and Global Clinical Solutions representatives • Ensure compliance with company ethics, policies, SOPs, 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 year) • An equivalency combining appropriate education, training and/or directly related experience may meet role requirements • Ability to work independently or in a team • 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 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 complete the organization's clinical training program • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Ability to manage risk and perform appropriate risk escalation • Occasional drives to site locations • Potential occasional travel required

🏖️ Benefits

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

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