Senior CRA – Level I

🕒 October 19

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Contribute to selecting potential investigators • Support study start-up and regulatory maintenance, including site qualification visits and submissions to EC/IRB and regulatory authorities where required • 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 Investigators meetings • Initiate, monitor, and close study sites in compliance with procedural requirements • Share patient recruitment and study-site progress information with the Local Study Team • Drive site performance and resolve or escalate study-related issues • Update CTMS and other systems with study-site data • Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction when applicable • Perform remote and onsite monitoring visits and remote data checks • Perform Source Data Review, Case Report Form review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity • Ensure timely data-query resolution and collaborate with data management on data quality • Ensure accurate and timely Serious Adverse Event reporting and follow-ups • Prepare and finalize monitoring visit reports in CTMS 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 in maintaining inspection-ready Investigator Site Files • Support audits and regulatory inspections • Ensure timely collection and uploading of essential documents to the eTMF • Prepare study documents for final archiving and completion of the local eTMF • Provide local-market research information on sites, investigators, and competing studies • Collaborate with local MSLs as directed

🎯 Requirements

• Minimum 3–5 years' experience as a monitor • Ability to work independently and monitor all stages of a study across different phases • Special therapeutic expertise in oncology • Ability to take on LST tasks and support LST coordination or document preparation as required • Ability to travel internationally as required • Valid driving license • Knowledge and compliance with ICH-GCP, AZ Procedural Documents, local regulations, and AZ SOPs • Ability to conduct remote and onsite monitoring visits • Experience with CTMS, eTMF, SDR, CRF review, and SDV • Ability to manage study supplies, drug supplies, and drug accountability • Ability to ensure timely reporting of Serious Adverse Events and follow-ups • Ability to support audits, regulatory inspections, and inspection readiness • Compliance with AstraZeneca’s Code of Ethics and company policies • Compliance with local, national, and regional legislation

🏖️ Benefits

• Fully remote work arrangement • Full-time employment

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