CRA / Sr. CRA

🕒 October 2

🇵🇪 Peru – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Perform and coordinate clinical monitoring and site management activities • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Identify site process failures and implement corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and perform trial closeout and material retrieval • Ensure essential documents are complete and conduct on-site file reviews • Track trial status and provide progress reports to the Clinical Team Manager • Update clinical trial management systems • 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 and timesheets • Assist with project publications and tools and contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field • Previous experience comparable to 1+ years as a clinical research monitor • International monitoring experience • Ability to conduct frequent drives to site locations • Frequent travel, generally 60–80%, with potential extended overnight stays • No restriction to travel internationally • Lives within an international airport location • Knowledge of clinical monitoring and site management processes • Knowledge of ICH-GCP guidelines, applicable regulations, and SOPs • Experience with risk-based monitoring, RCA, SDR, SDV, CRF review, investigational product assessment, and audit readiness • Ability to use clinical trial management systems

🏖️ Benefits

• Fully remote work arrangement • Frequent travel generally 60–80%, including potential extended overnight stays • No restriction to travel internationally

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