Senior CRA, FSP

🕒 5 days ago

🇨🇱 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 the selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and regulatory authority submissions where required • Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles • Confirm required site-staff training completion and maintain inspection readiness • Participate in Local Study Team meetings and National Investigators meetings as applicable • Initiate, monitor, and close study sites in compliance with applicable procedures • Share patient recruitment and site quality/performance information with the Local Study Team • Drive site performance, resolve study-related issues, and escalate issues appropriately • Update CTMS and other systems with site data within required timelines • Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction where applicable • Perform remote and onsite monitoring visits and remote data checks according to the study Monitoring Plan • Perform Source Data Review, Case Report Form review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity during the study • Ensure timely data-query resolution and collaborate with data management on study-data quality • Ensure accurate and timely reporting and follow-up of Serious Adverse Events • Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues • Assist sites in maintaining inspection-ready Investigator Site Files • Prepare for and collaborate on audits and regulatory inspections • Ensure timely collection and uploading of essential documents into the eTMF and support quality-control checks • Ensure study documents are ready for final archiving and completion of the local eTMF • Provide research-related market feedback on sites, investigators, and competing studies • Ensure compliance with AstraZeneca’s Code of Ethics, policies, procedures, and applicable legislation • 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 the LST with coordination or document preparation as required • Ability to travel internationally as required • Valid driving license • ICH-GCP knowledge and compliance • Ability to work in compliance with AZ Procedural Documents and relevant local regulations • Ability to complete monitoring, source data review, CRF review, and source data verification activities • Ability to manage study-site documentation, supplies, drug accountability, and essential documents • Ability to use CTMS and other study systems • Ability to ensure timely resolution of data queries and serious adverse event reporting • Ability to support audits, regulatory inspections, quality processes, and inspection readiness

🏖️ Benefits

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

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