Entry Level CRA

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

⚪️ Entry-level

👻 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 studies at allocated clinical research sites as an active participant in local study teams • Act as the main contact with study sites and monitor study conduct • Prepare, initiate, monitor, and close assigned study sites • Contribute to investigator selection and study start-up activities • Prepare and submit regulatory and ethics committee documentation where required • Train, support, and advise investigators and site staff on study-related matters and RBQM principles • Confirm completion of required site staff training and maintain inspection readiness • Participate in local study team and national investigator meetings • Track patient recruitment, site progress, and site quality/performance • Identify and resolve study-related issues and escalate them appropriately • Update CTMS and other systems with study-site data • Manage study and 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 query resolution and quality of collected study data • Report Serious Adverse Events and follow-ups accurately and promptly • Prepare monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate quality, privacy, CSP, and ICH-GCP compliance issues • Assist sites in maintaining inspection-ready ISFs • Support audits and regulatory inspections • Upload essential documents to the eTMF and support QC checks • Ensure study documents are ready for archiving and eTMF completion • Provide local-market research information on sites, investigators, and competing studies • Ensure compliance with AstraZeneca ethics, policies, procedures, and applicable legislation • 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

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