Senior Clinical Research Associate

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 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 • Manage required documentation and sponsor/monitoring-environment procedures • 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 SDR, SDV, and CRF review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigational sites between visits to confirm protocol compliance, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and issue/finding resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform CTMS report quality-control checks when required • Participate in investigator meetings and help identify and initiate qualified investigative sites • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications/tools and other study tasks assigned by the CTM • Facilitate communication among investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports, timesheets, and other administrative tasks • Contribute to project work and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor • Experience required in Oncology and Cell therapy • Valid driver's license where applicable • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application 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 • Effective oral and written communication skills with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work independently or in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including disclosure of vaccination status or other personal information where required • Ability to work in office, laboratory, clinical, and/or home-office environments • Ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible extended overnight stays • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves • Ability to tolerate fluctuating or extreme temperatures on rare occasions

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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