Clinical Research Associate

3 days ago

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000 employees

Founded 1961

Description

• The CRA executes clinical monitoring activities at clinical trial sites. • Monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. • Identifies gaps and areas for improvement and proposes CAPA. • Responsible for collaborating closely with the Clinical Study Manager to ensure study timelines are adhered to. • Conducts monitoring visits per monitoring plan and applicable SOPs. • Evaluates the quality and integrity of site practices and escalates quality and/or GCP issues as necessary. • Strives for operating excellence, questions status-quo, and promotes innovation.

Requirements

• BS in a relevant scientific discipline and minimum of 1 years of monitoring experience. • Experience in oncology global trials preferred. • Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook. • Thorough knowledge of ICH and associated regulatory guidelines. • 2-5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry preferred. • Excellent communication and interpersonal skills. • Excellent organizational skills and ability to prioritize and multi-task. • Fluent in English and Dutch (writing and speaking). • Travel: up to 60%.