Vanguard Clinical, Inc.
51 - 200 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
Biotechnology • Healthcare Insurance • Pharmaceuticals
Vanguard Clinical, Inc. is a boutique Contract Research Organization (CRO) and Functional Service Provider (FSP) that specializes in providing tailored services for clinical trial execution. With a focus on flexibility, transparency, and high-quality service, Vanguard Clinical partners with sponsor companies to manage their clinical development projects effectively. The company emphasizes careful handling of clients' assets, regulatory compliance, and optimal project management, offering a range of services from clinical monitoring and data management to patient recruitment and quality assurance.
Senior Clinical Research Associate – Pool
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Vanguard Clinical, Inc.
51 - 200 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
Biotechnology • Healthcare Insurance • Pharmaceuticals
Vanguard Clinical, Inc. is a boutique Contract Research Organization (CRO) and Functional Service Provider (FSP) that specializes in providing tailored services for clinical trial execution. With a focus on flexibility, transparency, and high-quality service, Vanguard Clinical partners with sponsor companies to manage their clinical development projects effectively. The company emphasizes careful handling of clients' assets, regulatory compliance, and optimal project management, offering a range of services from clinical monitoring and data management to patient recruitment and quality assurance.
📋 Description
• Primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites. • Independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3. • Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits. • Main point of contact between assigned sites and Sponsor. • Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements. • Delivers high quality and timely reports following each monitoring visit. • Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines. • Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites. • Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites.
🎯 Requirements
• 5+ years of independent clinical monitoring experience preferred • Excellent written and verbal communication skills including strong professional presentation skills (internal and external audiences) • Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements • Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.) • Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines.
🏖️ Benefits
• health insurance • 401k retirement plan • paid days off • annual performance bonus
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