FSP Clinical Research Associate I/II

🔥 2 hours ago

🇮🇱 Israel – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

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

• 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-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Monitor investigator sites using a risk-based monitoring approach • Perform root cause analysis and implement corrective/preventive actions • Ensure data accuracy through SDR, SDV and CRF 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 investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Track trial status and provide progress updates • Maintain accurate and current study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company and internal project teams • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications/tools and 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 • 1–2 years of experience as a Clinical Research Associate / Monitor • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Basic medical/therapeutic area knowledge and understanding of medical terminology • Working knowledge of ICH GCPs, applicable regulations and procedural documents • Good oral and written communication skills, including communication with medical personnel • Good interpersonal skills • Customer focus, listening skills and attention to detail • Organizational and time management skills • Flexibility and adaptability • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Willingness and ability to travel frequently (generally 60–80%), including possible overnight stays • Ability to work in office, laboratory, clinical and/or home office environments • Ability to use required personal protective equipment and work around biological fluids/infectious organisms

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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