CRA II

🕒 September 8

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 21%

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 and guidelines across FSO, FSP, Government, and other monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects' rights and well-being and ensure data reliability • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving • 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 and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and make recommendations regarding site acceptability • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress reports to the Clinical Team Manager • Update clinical trial management systems according to study conventions • Facilitate communication among sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports, timesheets, and other administrative tasks • Assist with project publications and tools and contribute ideas to team members • 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 • At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience • Valid driver's license where applicable • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills • Ability to communicate effectively with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Good organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently and in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in environments with potential exposure to biological fluids and infectious organisms • Ability to use required personal protective equipment

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Personal protective equipment provided/required for applicable work • Opportunity to work with a global team and support leading pharmaceutical companies and biotechs • Professional development through exposure to diverse sponsors, monitoring environments, clinical trials, and project initiatives

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