Senior CRA

🔥 21 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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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

• Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and procedures • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs • Develop collaborative relationships with investigational sites and client company personnel • Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site process failures • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • 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 • Identify potential investigators and initiate clinical trial sites • 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 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 • Contribute to project initiatives and process improvements

🎯 Requirements

• Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification • Considerable clinical research monitoring experience comparable to 5+ years • Demonstrated high level of expertise in all aspects of clinical monitoring • Expert clinical monitoring skills • Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents • Excellent critical thinking, root cause analysis and problem-solving skills • Proficient in Risk Based Monitoring concepts and processes • Ability to evaluate medical research data and proficient knowledge of medical terminology • Excellent oral and written communication skills • Ability to maintain customer focus • Excellent interpersonal skills • Excellent organizational and time management skills • Strong attention to detail • Ability to remain flexible and adaptable • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to work in an office, laboratory, clinical, and/or home office environment • Frequent travel, generally 60–80%, including possible extended overnight stays • Ability to work in an upright and/or stationary position for 6–8 hours per day • Ability to lift and carry objects, luggage, and laptop computer weighing up to 15–20 lbs • Regular and consistent attendance

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility assistance or accommodation during the job application process

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