Clinical Research Associate II

🔥 32 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🧪 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 clinical monitoring documentation, procedures and sponsor guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs • Build collaborative relationships with investigational sites and client company personnel • Support project and clinical team managers and mentor junior clinical team members • Monitor investigator sites using risk-based monitoring, including root cause analysis, SDR, SDV and CRF review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems and reports • Participate in investigator meetings and identify qualified investigative sites • Initiate clinical trial sites and support trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, newsletters, trip report reviews and CRA team calls • Facilitate communication between sites, clients and the PPD 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 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 • Frequent travel, generally 60–80%, potentially including extended overnight stays • Ability to work in an office, laboratory, clinical and/or home office environment • Ability to work in an upright and/or stationary position for 6–8 hours per day • Frequent mobility required • Ability to lift and carry objects weighing up to 15–20 lbs • Ability to use a variety of computer software • Regular and consistent attendance

🏖️ Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits • Career and development prospects • Innovative, forward-thinking organization • Exciting company culture • Accessibility assistance or accommodation during the job application process for eligible job seekers

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