Senior Clinical Research Associate

🕒 October 15

🇲🇽 Mexico – 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

• Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation, procedures, and sponsor guidelines • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Develop collaborative relationships with investigational sites and client company personnel • Assist project managers and clinical team managers on assigned projects • Mentor, train, and contribute to the 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 identify site process failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational products through physical 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 clinical study systems, including CTMS, and perform required quality-control checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and properly maintained • Conduct on-site file reviews • Assist with project publications and tools and contribute process-improvement ideas • Perform additional study tasks such as trip report reviews, newsletters, and leading CRA team calls • Facilitate communication between investigative sites, clients, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets • Contribute to other project work and initiatives as required

🎯 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 clinical monitoring skills • 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 • Ability to evaluate medical research data and 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 • Frequent mobility required • Ability to lift and carry 15–20 lbs • Ability to access and use a variety of computer software • Ability to communicate complex information effectively • Regular and consistent attendance

🏖️ Benefits

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

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