CRA II

🔥 11 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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 • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Support subject rights, well-being, data reliability, and audit readiness • Develop collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions • Ensure data accuracy through source data review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters, escalate deficiencies, and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical trial systems, including CTMS, and perform report quality-control checks • Participate in investigator meetings and identify qualified investigative sites • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication between investigative sites, the client company, and the project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to process-improvement initiatives and other project work

🎯 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 may be considered through a combination of appropriate education, training, and directly related experience • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and 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 with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Effective interpersonal, 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 • Ability to comply with sponsor/client/site requirements, including potential disclosure of vaccination status or other personal information • Ability to travel frequently, generally 60–80%, with frequent drives to site locations and possible extended overnight stays • Ability to use required personal protective equipment when applicable

🏖️ Benefits

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

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