Senior Clinical Research Associate

🕒 September 8

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 21%

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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 required documentation and sponsor/monitoring procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • 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 failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product through inventory and records review • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigational 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, including CTMS, and perform quality-control checks of CTMS reports • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and support trial closeout and retrieval of 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, the client company and the 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 sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • 2+ years of experience as a clinical research monitor • Valid driver's license where applicable • Experience required in Oncology and Cell therapy • 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, organizational and time management skills • Flexibility and adaptability • Ability to work in a team or independently • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with specific sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information

🏖️ Benefits

• Frequent travel, generally 60-80% but more for some individuals • Work is performed in an office/ laboratory/clinical/and/or home office environment • Personal protective equipment provided/required, including protective eyewear, garments and gloves

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