Thermo Fisher Scientific
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.
Clinical Research Associate II – FSP
🔥 0 minutes ago
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Thermo Fisher Scientific
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
• 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 during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in timely reports and letters • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payments and investigator meetings • Identify potential investigators and qualified investigative sites with the client company • Initiate clinical trial sites in compliance with protocol, regulatory, and ICH GCP obligations • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and in place • Conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including the Clinical Trial Management System • Facilitate communication among investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets • Assist with project publications and tools • Contribute to project work and process-improvement initiatives
🎯 Requirements
• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification • Valid driver's license where applicable • Approximately 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Combination of appropriate education, training, and/or directly related experience may be considered equivalent • Proven clinical monitoring skills • Understanding of medical/therapeutic areas and medical terminology • Working knowledge 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 • Good oral and written communication skills, including communication with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues • Organizational and time-management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or as part of a team
🏖️ Benefits
• Comprehensive health and wellbeing benefits • Wellness programs • Employee Assistance Program • Flexible work arrangements • Generous leave policies • Option to purchase additional leave • Paid birthday leave • Company-paid parental leave • Paid volunteer time • Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning • Workshops • Mentorship programs
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