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CRA / Sr CRA

🕒 5 days ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 5 days ago

Still open on Thermo Fisher Scientific's site. Checked 1 hour ago.

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Conduct on-site and remote monitoring visits using a risk-based monitoring approach • Review source documentation, case report forms (CRFs), and study data for accuracy, completeness, and compliance • Perform site management activities, including site initiation, routine monitoring, and close-out visits • Assess investigational product accountability through inventory and records review • Identify site process issues, perform root cause analysis, and support corrective and preventive actions • Maintain essential documents according to ICH-GCP and regulatory requirements • Prepare monitoring reports, follow-up letters, and study documentation within established timelines • Communicate with investigational sites, sponsors, and internal study teams • Support site identification, feasibility, and investigator engagement activities • Track study progress and maintain records in clinical trial management systems and other study tools • Support regulatory inspections, audits, and quality initiatives • Contribute to process improvements, project deliverables, and knowledge sharing across teams • Safeguard subject safety, data integrity, audit readiness, and overall study quality

🎯 Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related healthcare field, or an equivalent combination of education and experience • Valid driver’s license, where applicable • Ability to travel as required • Relevant clinical research and/or clinical monitoring experience in a pharmaceutical, biotechnology, CRO, or healthcare environment • Knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulations • Understanding of medical terminology and therapeutic areas • Strong critical thinking, problem-solving, and root cause analysis skills • Experience with Risk-Based Monitoring (RBM) methodologies • Excellent organizational and time management skills • Strong written and verbal communication skills, including professional interaction with investigators and site personnel • Ability to work independently and collaboratively in a global team environment • Proficiency with Microsoft Office and clinical trial systems • Strong attention to detail and commitment to quality • English proficiency required • Frequent travel, generally 60–80%, with possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves • Potential exposure to biological fluids, infectious organisms, electrical office equipment, and fluctuating or extreme temperatures

🏖️ Benefits

• Fully remote work mode • Full-time employment • Standard Monday–Friday schedule

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