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 required clinical trial 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 managers or clinical team managers and lead where required • Mentor, train and contribute to developing junior clinical team members • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product inventory and records • Prepare timely reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Participate in investigator payment processes and findings resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems and reports • Participate in investigator meetings and identify qualified investigators/sites • Initiate clinical trial sites and ensure regulatory and ICH-GCP compliance • Conduct trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools and additional study tasks • Facilitate communication between sites, client company and project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to 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 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 • Ability to utilize problem-solving techniques in a constantly evolving environment • Good digital literacy and proficient knowledge of Microsoft Office • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in an upright and/or stationary position 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 clearly • Regular and consistent attendance

🏖️ Benefits

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

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