Senior Clinical Research Associate I

🔥 3 minutes ago

🇮🇱 Israel – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Manage and monitor assigned investigator sites from site initiation through database lock and close-out • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Serve as primary contact for assigned investigator sites during study conduct • Facilitate information flow among study team members, vendors and investigator sites • Coach and train site personnel and provide protocol training • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress updates • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and undertake unblinded monitor responsibilities when required • Maintain knowledge of the product, protocol and therapy area • Support patient safety, eligibility and clinical guidance for investigators • Drive Quality Event remediation and audit observation CAPA development when applicable

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 3 years of relevant experience in clinical research site monitoring • Preferably 2 years in Oncology • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Fluent in English and the native language(s) of the country they will work in • Valid driver’s license and passport required • Significant travel (60–80%) within area required • May require international and weekend travel

🏖️ Benefits

• Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion • Equal employment opportunities • Significant travel within the area and possible international travel

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