Senior Clinical Research Associate

🔥 6 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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

• Conduct and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required documentation and sponsor procedures • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs • Develop collaborative relationships with investigative sites and client personnel • Assist project or clinical team managers and lead activities when required • Mentor, train, and support development of junior clinical team members • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to resolve site process failures • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical study systems and perform CTMS report quality checks • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and ensure compliance with regulatory and ICH-GCP obligations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, clients, and the PPD 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

🎯 Requirements

• Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification • Considerable clinical research monitoring experience comparable to 5+ years • Demonstrated high level of expertise in all aspects of clinical monitoring • Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents • Excellent critical thinking, root cause analysis and problem-solving skills • Proficient in Risk Based Monitoring concepts and processes • Demonstrated ability to evaluate medical research data • Proficient knowledge of medical terminology • Excellent oral and written communication skills • Ability to maintain customer focus • Excellent interpersonal, organizational and time management skills • Strong attention to detail • Flexibility and adaptability in a wide range of scenarios • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to work in an office, laboratory, clinical, and/or home office environment • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work upright and/or stationary for 6–8 hours per day • Ability to lift and carry 15–20 lbs • Regular and consistent attendance

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Employee accessibility services and accommodations during the application process