Clinical Research Associate I, Bilingual French

🔥 13 minutes ago

🇨🇦 Canada – 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 and on-site visits to assess protocol and regulatory compliance • Manage required documentation and sponsor-specific procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects' rights and well-being and ensure data reliability and audit readiness • Develop 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 through inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow issues through resolution • Conduct monitoring tasks 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 accurate and current study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, client companies, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Assist with project publications and tools and contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Minimal clinical monitoring experience comparable to 2 years (24 months) in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, 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 understanding of medical terminology • Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills, including communication with medical personnel • Good interpersonal, organizational, and time-management skills • Customer-focus, listening skills, attention to detail, and ability to identify underlying issues • Flexibility and adaptability • Well-developed 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 and French language and grammar skills • Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home-office environments and use required personal protective equipment

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Exposure to varied clinical research projects and monitoring environments • Professional collaboration with global pharmaceutical, biotech, client, and internal project teams • Opportunity to contribute to project publications, tools, and process-improvement initiatives

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