Clinical Research Associate II

🔥 11 minutes ago

🇲🇽 Mexico – 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 sponsor procedures and guidelines across different monitoring environments • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • 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 case report form review • Assess investigational product inventory and records • Document observations in reports and letters using approved business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes • Investigate and follow up on findings • Participate in investigator meetings • Identify potential investigators and support selection of qualified investigative sites • Initiate clinical trial sites according to applicable procedures and regulatory obligations • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and regulations • Conduct on-site file reviews • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems such as Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications and tools • Contribute ideas, process improvements and other project initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation 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 • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to use required personal protective equipment

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Frequent travel and site visits as part of the role • Personal protective equipment such as protective eyewear, garments and gloves

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