Senior CRA, Level I

🕒 July 31

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 48%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 and on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures, guidelines, documentation and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Monitor investigator sites using risk-based monitoring, including RCA, SDR, SDV and CRF review • Assess investigational product inventory and records • Document observations, escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress reports to the Clinical Lead • Update and quality-check study systems, including CTMS • Participate in investigator meetings and identify qualified investigators and sites • Initiate clinical trial sites and ensure trial close-out and material retrieval • Ensure essential documents are complete and conduct on-site file reviews • Support project publications, tools, trip report reviews, newsletters and CRA team calls • Facilitate communication among investigative sites, the client and the project team • Respond to company, client and regulatory audits and inspections • Complete expense reports and timesheets • Contribute to process-improvement initiatives and other project work

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 2+ years as a clinical research monitor • An equivalency combining appropriate education, training and/or directly related experience may be sufficient • 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 and attention to detail • Interpersonal, 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 vaccination-status or personal-information disclosures where required

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