Clinical Research Associate I

🔥 13 hours ago

🇨🇱 Chile – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Contribute to selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification visits and regulatory submissions where required • Train, support and advise investigators and site staff on study-related matters, including RBQM principles • Confirm required site staff training and maintain inspection readiness • Participate in local study team and national investigator meetings • Initiate, monitor and close study sites in compliance with procedures • Share patient recruitment and site progress information with the local study team • Drive site performance, identify and resolve study-related issues, and escalate as appropriate • 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 Source Data Review, Case Report Form review and Source Data Verification • Perform site quality risk assessments and adapt monitoring intensity • Ensure timely data query resolution and accurate Serious Adverse Event reporting • Prepare and finalize monitoring visit reports in CTMS 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 Investigator Site Files • Support audits and regulatory inspections • Collect and upload essential documents into the eTMF and prepare documents for final archiving • Provide local-market research information on sites, investigators and competing studies • Ensure compliance with company policies, ethics codes 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 language • Degree in scientific discipline or health care, or equivalent combination of education, training and experience may be accepted in lieu of degree

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