Clinical Research Associate I

🕒 5 days ago

🇨🇴 Colombia – 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 document review, source data verification and case report form review • Assess investigational product 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 investigator payment processes and investigator meetings • Help identify potential investigators and initiate clinical trial sites in compliance with protocols, regulations 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 according to project specifications • Provide trial status tracking and progress updates • Keep study systems complete, accurate and updated, including Clinical Trial Management Systems • Facilitate communication between investigative sites, the client company and internal project teams • Respond to company, client and regulatory requirements, audits and inspections • Complete administrative tasks such as expense reports and timesheets • Assist with project publications and tools, share suggestions, and contribute to 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 in a 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 conduct risk-based monitoring and apply root cause analysis, critical thinking and problem-solving skills • Knowledge of ICH-GCP, applicable regulations, clinical trial protocols and monitoring plans • Ability to use clinical trial systems, including Clinical Trial Management Systems • Ability to comply with sponsor, client and site requirements, including disclosure of vaccination status or other personal information when required • Ability to travel frequently, generally 60–80%, with a stated travel requirement higher than 75% • Ability to make frequent drives to site locations and undertake extended overnight stays • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to work in fluctuating and/or extreme temperatures on rare occasions

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Work performed in office/laboratory/clinical and/or home office environments • Personal protective equipment provided/required, including protective eyewear, garments and gloves

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