Clinical Research Associate I

🕒 5 days ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Deliver clinical studies at allocated sites as part of the local study team • 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-related matters and RBQM principles • Confirm required site staff training and maintain inspection readiness • Participate in local study team and national investigator meetings • Drive site performance, identify and resolve study issues, and escalate appropriately • Update CTMS and other systems with study-site data • Manage study, drug, and study-supply 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 collaborate with data management on data quality • Report Serious Adverse Events and follow-ups accurately and promptly • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate quality, data privacy, CSP, or ICH-GCP compliance issues • Assist sites in maintaining inspection-ready ISFs • Support audits and regulatory inspections • Collect and upload essential documents to the eTMF and prepare documents for archiving • Provide local market research-related feedback on sites, investigators, and competing studies • Ensure compliance with AstraZeneca policies, Code of Ethics, legislation, and applicable regulations • 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 may be accepted in lieu of degree

🏖️ Benefits

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

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