Senior CRA I/II - FSP

🔥 2 hours ago

🇪🇸 Spain – 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.

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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

• Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through source data review, source data verification, and CRF review during on-site and remote monitoring • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies to clinical management • Follow issues through resolution and maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including the Clinical Trial Management System, and perform report quality control checks • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites in compliance with protocols, regulations, and ICH GCP obligations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations • Conduct on-site file reviews • Assist with project publications and tools and contribute ideas to the project team • Perform additional study tasks assigned by the Clinical Team Manager • Facilitate communication between investigative sites, the client company, and the project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets • Contribute to project work and process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life science related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • At least 3 years of experience as a CRA • At least 2 years of on-site, hands-on cell therapy experience • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills • Ability to communicate effectively with medical personnel • Customer focus, listening skills, attention to detail, and ability to perceive underlying issues • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills

🏖️ Benefits

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

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