Senior Clinical Research Associate, Level II

🔥 12 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 15%

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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 and manage required documentation • Manage sponsor procedures and guidelines across different monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects’ rights and well-being and ensure data reliability • Ensure audit readiness and build collaborative relationships with investigational sites • 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 inventory and records • Prepare timely reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring according to approved monitoring plans • Participate in investigator payment processes and investigator meetings • Help identify qualified investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Track trial status and provide progress updates • Maintain complete and accurate study systems, including clinical trial management systems • Facilitate communication among sites, clients, and internal project teams • Respond to client, company, and regulatory audits and inspections • Complete expense reports and timesheets • Support project publications, tools, process improvements, and other project initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Minimum 2 years of clinical monitoring experience, or comparable experience in clinical trials, medical terminology, medical research, clinical research, healthcare, or a health sciences field with formal training in medical terminology and anatomy • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Basic medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills • Good interpersonal, organizational, and time management skills • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Flexibility and adaptability • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage risk-based monitoring concepts and processes • Ability to work independently or as part of a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Ability to travel frequently, generally 60–80%, including potential extended overnight stays

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work with a global team • Potential professional exposure across clinical trials, sponsors, and monitoring environments

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