Senior CRA, FSP

🔥 0 minutes ago

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume