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 and participate in local study teams • Act 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 completion and documentation of required site staff 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 study-site data • Manage study, drug supplies and drug accountability • Perform remote and on-site monitoring visits and remote data checks • Perform SDR, CRF review, SDV and site quality risk assessments • Ensure timely data-query resolution and accurate Serious Adverse Event reporting • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality issues, data privacy breaches and compliance issues • Assist sites with maintaining 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 • Provide local-market research feedback and collaborate with local MSLs • Ensure compliance with ethics, company policies, legislation and safety requirements

🎯 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 • Ability to comply with AZ Procedural Documents, ICH-GCP, local regulations, company policies and procedures • Ability to perform remote and on-site monitoring visits • Ability to use CTMS and other study systems • Ability to perform Source Data Review, Case Report Form review and Source Data Verification

🏖️ Benefits

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

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