Principal CRA

🔥 1 hour ago

🇲🇽 Mexico – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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 different monitoring environments • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Protect subjects' rights, well-being and data reliability • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify site-process failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring • Assess investigational product through inventory and records review • 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 • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems such as CTMS and perform required quality-control checks • Participate in investigator meetings and identify potential qualified investigators • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, newsletters, trip report reviews and CRA team calls • Facilitate communication between sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to project work and process-improvement initiatives • Travel frequently to site locations, generally 60–80%, with possible extended overnight stays

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • 2+ years as a clinical research monitor • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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 • Ability to communicate effectively with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal skills • Strong organizational and time management skills • Flexibility and adaptability • Ability to work independently and as part of 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 possible vaccination-status or other personal-information disclosures

🏖️ Benefits

• Fully Remote work arrangement • Standard Monday-Friday work schedule • Opportunity to work with a global team • Exposure to diverse clinical trials and pharmaceutical/biotech projects • Professional involvement in clinical research innovation and process improvement initiatives