Senior Clinical Research Associate

🕒 October 9

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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, and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters; escalate and follow deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress reports to the Clinical Team Manager • Update clinical study systems and perform required quality-control checks • Participate in investigator meetings and identify qualified investigators and sites • Initiate clinical trial sites and ensure trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Support project publications, tools, team calls, and other study tasks • Facilitate communication among investigative sites, the client company, and the project team • Respond to company, client, regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to project work and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor • On-site monitoring experience in Rare Diseases and Alzheimer's clinical trials • Valid driver's license where applicable • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated 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 • Effective interpersonal, organizational, and time management skills • Strong attention to detail • Ability to work independently and 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 other personal-information disclosures where required • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to use required personal protective equipment and work around biological fluids and infectious organisms

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Frequent travel expenses likely covered as part of business travel (not explicitly stated)

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