Senior Clinical Research Associate

🔥 2 hours ago

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 2 hours ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 investigator site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs • Build collaborative relationships with investigative sites and client personnel • Apply risk-based monitoring, root cause analysis and corrective/preventive actions • Ensure data accuracy through 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 reports to the Clinical Team Manager • Update clinical trial systems, including CTMS, and perform report quality checks • Participate in investigator meetings and identify qualified investigators • Initiate clinical trial sites and ensure trial closeout and material retrieval • Ensure essential documents are complete and conduct on-site file reviews • Support project publications, tools and additional study tasks • Facilitate communication among sites, clients 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 improvement

🎯 Requirements

• Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification • 5+ years of clinical research monitoring experience or comparable experience • 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 • Proficient knowledge of medical terminology • Excellent oral and written communication skills • Ability to maintain customer focus • Excellent interpersonal, organizational and time management skills • Strong attention to detail • Flexibility and adaptability • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to travel frequently, generally 60–80%, with possible extended overnight stays • Ability to work in an office, laboratory, clinical and/or home office environment • Ability to work upright and/or stationary for 6–8 hours per day • Ability to lift and carry 15–20 lbs • Regular and consistent attendance

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Range of employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility assistance or accommodations during the job application process for job seekers with disabilities

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🇨🇱 Chile – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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