Senior Clinical Research Associate

🕒 5 days ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage clinical monitoring and site management processes and required documentation • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site process failures 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 through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes and findings resolution • Provide trial status tracking and progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems and reports • Participate in investigator meetings and identify qualified investigative sites • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Maintain essential documents and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, client company personnel, 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 • Support mentoring, training, and development of junior clinical team members

🎯 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 skills • Excellent organizational and time management skills • Strong attention to detail • Ability to remain flexible and adaptable • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work with required personal protective equipment and potential exposure to biological fluids/infectious organisms • Ability to work upright and/or stationary for 6–8 hours per day • Ability to lift and carry up to 15–20 lbs • Regular and consistent attendance

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility assistance or accommodation during the job application process

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