Senior Clinical Research Associate

April 4

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UBC

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UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

Evidence Development • Modernized Study Design & Execution • Late-Stage Research • Risk Evaluation & Mitigation Strategies • Pharmacovigilance

1001 - 5000 employees

Founded 2003

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow • We take pride in improving patient outcomes and advancing healthcare • Specific job duties include thorough knowledge and application of project specific protocol • Consistently completes on-site monitoring in accordance with project specific timelines • Consistently completes travel scheduling in accordance with project specific and UBC guidelines • Attends project team meetings, department meetings and minimum of monthly 1:1 with manager • Completes site monitoring reports and confirmation/follow-up letters per UBC and/or client SOPs • Ensures follow-up of site issues and action items per UBC/sponsor timelines • Enters site visits and monitoring reports into UBC’s Clinical Trial Management System • Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol • Monitors within Electronic Data Capture data entry and assists sites with Case Report Form resolution • Completes Regulatory Binder and Investigational Product reconciliation • Maintains regular contact with assigned sites per study requirements • Consistently submits expense reports and completes SOP reviews and documentation

🎯 Requirements

• Bachelor’s degree – Life Science preferred or equivalent years of industry and monitoring experience • Minimum of 5 years experience in current role and / or related function • Minimum of 1 years experience at a Service Provider • Minimum of 3 years experience in Oncology trials and 1 year experience in Ophthalmology • Phase 1 experience required; solid tumor experience preferred • Thorough knowledge of medical terminology • Good written and verbal communication skills • Consistently meets or exceeds metrics for quality trip reports and letters • Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation • Ability to perform tasks in UBC’s Clinical Trial Management System, Electronic Data Capture System, Outlook and client specific systems (if applicable) • Thorough knowledge of International Conference on Harmonisation, Good Clinical Practice guidelines, Code of Federal Regulations and UBC SOPs

🏖️ Benefits

• Equal opportunity employer • Diverse, equitable and inclusive culture