Clinical Research Associate I

🕒 5 days ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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 data review, source data verification, and case report form review during on-site and remote monitoring • Assess investigational products through physical inventory and records review • 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 to confirm protocol compliance, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in the investigator payment process and investigator meetings • Identify potential investigators and initiate clinical trial sites according to procedures, protocol, regulatory, and ICH-GCP obligations • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations • Conduct on-site file reviews • Provide trial status tracking and progress updates • Maintain complete and accurate study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Assist with project publications/tools and contribute ideas and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent formal academic/vocational qualification • Minimal clinical monitoring experience comparable to 2 years • Clinical environment experience in clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology • Ability to perform root cause analysis, critical thinking, and problem-solving • Knowledge of ICH-GCP, applicable regulations, and clinical trial procedures • Ability to travel generally 60–80%, with a travel requirement higher than 75% • Ability to perform frequent drives to site locations and extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to comply with sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information • Ability to use required personal protective equipment when exposed to biological fluids or infectious organisms

🏖️ Benefits

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

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