Senior Clinical Research Associate - Medical Device

🔥 2 minutes ago

🇺🇸 United States – 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 and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis and corrective/preventive actions • Ensure data accuracy through source data 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 • Track trial status and provide progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and support trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters and CRA team calls • Facilitate communication among investigative sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • Contribute to project work and 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 • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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, including communication with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal, organizational and time management skills • Ability to remain flexible and adaptable • Ability to work independently or in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosures • Ability to use required personal protective equipment • Ability to travel frequently, generally 60-80%, including possible extended overnight stays

🏖️ Benefits

• Frequent travel, generally 60-80% but more for some individuals • Remote work arrangement with remote and on-site monitoring activities • Standard Monday-Friday work schedule