Senior Clinical Research Associate, Level II

🕒 October 9

🇦🇷 Argentina – 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

• 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, monitoring environments, and required documentation • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach, including root cause analysis and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and case report form review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow issues through resolution • Participate in investigator meetings and help identify qualified investigators and sites • Initiate sites, perform trial closeout, and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Track trial status, provide progress updates, and maintain study systems such as Clinical Trial Management Systems • Facilitate communication among investigative sites, client companies, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports, timesheets, and other administrative tasks • Contribute to project publications, tools, process improvements, and other project initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • At least 2 years of clinical monitoring experience in a clinical environment, including clinical trials, medical terminology, medical research, clinical research, or health care; alternatively, health sciences experience with formal training in medical terminology and anatomy may be considered • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Basic medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills with medical personnel • Good interpersonal, organizational, and time management skills • Critical thinking, root cause analysis, problem-solving, risk-based monitoring concepts and processes • Ability to work independently or as part of a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Ability to travel frequently, generally 60–80%, including possible overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

🏖️ Benefits

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

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