Senior Clinical Research Associate – FSP

🔥 12 minutes ago

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

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

• Independently monitor clinical studies through all stages and phases, with a focus on oncology. • Take local responsibility for study delivery at allocated sites and act as the main site contact. • Prepare, initiate, monitor, and close assigned clinical study sites. • Contribute to investigator selection and national investigator meetings. • Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and regulatory submissions where required. • Train, support, and advise investigators and site staff on study-related matters and RbQM principles. • Participate in Local Study Team meetings and support LST coordination or document preparation. • Confirm completion and documentation of required site staff training, including ICH-GCP training. • Drive site performance, identify study issues, ensure timely resolution, and escalate appropriately. • Update CTMS and other systems with site data within required timelines. • Manage study supplies, drug supplies, drug accountability, and drug destruction preparation where applicable. • Conduct remote and onsite monitoring visits and remote data checks according to the Monitoring Plan. • Perform Source Data Review, CRF 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 study data quality. • Ensure accurate and timely Serious Adverse Event reporting and follow-up. • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators. • Follow up on outstanding site actions and escalate systematic or serious quality and compliance issues. • Assist sites with inspection-ready ISFs and support audits and regulatory inspections. • Ensure timely collection and uploading of essential documents to the eTMF and support QC checks. • Ensure study documents are ready for final archiving and completion of the local eTMF. • Provide useful research-related intelligence about sites, investigators, and competing studies for the local market. • Ensure compliance with AstraZeneca 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 LST coordination or document preparation as required • Ability to travel internationally as required • Valid driving license • Knowledge and application of ICH-GCP, AZ Procedural Documents, SOPs, and relevant local regulations • Ability to train, support, and advise investigators and site staff • Ability to ensure site inspection readiness and required training documentation • Ability to perform monitoring visits, remote data checks, SDR, CRF review, and SDV • Ability to manage study supplies, drug supplies, and drug accountability • Ability to resolve data queries and ensure timely Serious Adverse Event reporting • Ability to prepare monitoring visit reports and maintain CTMS/eTMF documentation • Ability to identify, escalate, and resolve quality, compliance, and data privacy issues • Ability to collaborate with Local Study Teams, data management, MSLs, LSAD, CQAD, and regulatory stakeholders

🏖️ 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