Senior Clinical Research Associate

🔥 1 hour ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

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.

📋 Description

• Monitor clinical trials and observational studies for protocol adherence • Manage site activities and oversee data collection and integrity • Ensure sites conduct studies and report data according to regulations, guidelines, and sponsor requirements • Apply project-specific protocols • Perform remote and on-site monitoring according to project timelines • Schedule travel according to project and UBC travel policies • Submit expense reports within UBC requirements • Attend project, department, and one-to-one manager meetings • Complete site monitoring reports and letters with minimal corrections • Follow up on site issues and action items within required timelines • Enter site visits, monitoring reports, follow-up letter dates, and site contacts into CTMS • Monitor EDC data entry and assist with eCRF resolution • Review Investigator Site Files and reconcile Investigational Product • Maintain regular contact with assigned sites • Complete SOP reviews, training assessments, and documentation • Perform Site Management and Monitoring activities according to project plans and timelines • Review and update Patient Information Sheets and Informed Consent documents according to local requirements • Translate study communications between English and the local language as needed • Prepare, submit, and track CTIS, Competent Authority, and Ethics Committee regulatory applications • Conduct contract negotiations with sites, foundations, and local Research & Development departments • Review and confirm site payment details • Maintain eTMF and track essential documents • Conduct study feasibility assessments with sites • Perform other assigned duties that may align with other UBC departments

🎯 Requirements

• Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience • Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring • Preferably at least 6 months’ on-site monitoring experience • Knowledge of medical terminology and regulatory guidelines, including local legislation • Strong attention to detail and excellent organizational skills • Ability to communicate effectively • Excellent critical thinking and resolution skills • Ability to deliver accurate work and adhere to deadlines in a fast-paced environment • Good written and verbal communication skills in English and local language, as applicable • Experience and familiarity with CTMS, eTMF, EDC, and Microsoft Office applications • Willingness and ability to travel up to 50% in the European region

🏖️ Benefits

• Equal opportunity employer • Diverse, equitable and inclusive workplace culture • Career growth and meaningful impact opportunities