FSP CRA I/II

🔥 4 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🧪 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.

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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 for one specific sponsor • Conduct remote and on-site visits to assess protocol and regulatory compliance • 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 and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits to verify protocol compliance, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes, investigator meetings, site qualification, site initiation, 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 • Provide trial-status tracking and progress updates to the Clinical Team Manager • Update study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Support project publications, tools, and process-improvement initiatives • Develop collaborative relationships with investigational sites and ensure audit readiness

🎯 Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Proven clinical monitoring skills • Understanding of medical/therapeutic areas and medical terminology • Working knowledge 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 • Good oral and written communication skills • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or as part of a team • Solid Microsoft Office knowledge and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home-office environments • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Remote or on-site visit flexibility • Professional experience supporting global clinical trials • Exposure to project publications, tools, and process-improvement initiatives

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