Clinical Research Associate I

🔥 14 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 12%

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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

• Deliver assigned clinical studies at allocated sites as an active member of local study teams • Serve as the main contact for study sites and monitor study conduct • Prepare, initiate, monitor, and close assigned clinical study sites • Contribute to investigator selection and, where applicable, study start-up and regulatory maintenance • Train, support, and advise investigators and site staff on study matters and RBQM principles • Confirm completion and documentation of required site training, including ICH-GCP training • Participate in local study team and national investigator meetings • Drive site performance and resolve or escalate study-related issues • Update CTMS and other systems with site data within required timelines • Manage study supplies, drug supplies, and drug accountability • Perform remote and on-site monitoring visits, remote data checks, SDR, CRF review, and SDV • Conduct site quality risk assessments and adapt monitoring intensity • Ensure timely data-query resolution and work with data management on study-data quality • Ensure accurate and timely reporting of serious adverse events and follow-ups • Prepare and finalize monitoring visit reports and provide feedback to principal investigators • Follow up on outstanding site actions • Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues • Assist sites with inspection-ready investigator site files • Support audits and regulatory inspections • Collect and upload essential documents to the eTMF and support quality-control checks • Ensure study documents are ready for final archiving and local eTMF completion • Provide local-market research information and collaborate with local MSLs as directed

🎯 Requirements

• 0–2 years of prior relevant experience • Good knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines • Written and verbal communication skills • Good command of English • Degree in a scientific discipline or health care, or equivalent combination of education, training and experience accepted in lieu of degree • Compliance with AstraZeneca procedural documents, SOPs, Code of Ethics, company policies, and applicable legislation • Ability to perform remote and on-site monitoring visits • Ability to manage clinical study documentation, regulatory submissions, site records, CTMS/eTMF updates, study supplies, and drug accountability

🏖️ Benefits

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

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