Clinical Research Associate, CRA

🔥 16 hours ago

🇮🇱 Israel – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

infoinfo

🗣️🇮🇱 Hebrew Required

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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 clinical trial documentation and ensure audit readiness • Monitor investigator sites using a risk-based monitoring approach • Identify site process failures and implement corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters • Escalate deficiencies and follow issues 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 initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and compliant with ICH-GCP and regulations • Track trial status and provide progress reports • Maintain accurate and current study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, clients, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to project publications, tools, process improvements, and other initiatives • Travel more than 75%

🎯 Requirements

• Bachelor's degree in a life sciences related field • At least 1 year of clinical monitoring experience in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy • Valid driver's license where applicable • Equivalency may be considered through a combination of appropriate education, training and/or directly related experience • Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills with medical personnel • Good interpersonal skills • Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues • Good organizational and time management skills • Flexibility and adaptability • Well-developed 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 and Hebrew language and grammar skills

🏖️ Benefits

• Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Award-winning learning and development programme • Collaborative environment with opportunities to share expertise • Professional and personal growth opportunities

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