Senior CRA - FSP

🔥 28 minutes ago

🇮🇹 Italy – 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

• Perform and coordinate clinical monitoring and site management activities • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor/monitoring-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • 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 document review, source data verification and CRF review • Assess investigational product through inventory and records review • Document observations in reports and letters; escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform required quality-control checks • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and make recommendations regarding site acceptability • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and properly maintained • Conduct on-site file reviews • Assist with project publications, tools and other study tasks • Facilitate communication among investigative sites, client companies and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • Contribute to process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor, or comparable experience • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • 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 • Effective interpersonal, organizational and time management skills • Strong attention to detail • 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 • Ability to comply with sponsor/client/site requirements, including potential disclosure of vaccination status or other personal information • Ability to work in office, laboratory, clinical and/or home-office environments • Ability to travel frequently, generally 60–80%, including drives to site locations and possible overnight stays • Ability to use required personal protective equipment and work around biological fluids and potentially infectious organisms

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Frequent travel and potential extended overnight stays as required by the role

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