Clinical Research Associate

Job not on LinkedIn

🕒 March 9

🌵 Arizona, California, +13 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🌪️ Kansas – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🌪️ Oklahoma – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $90k - $130k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Vanguard Clinical, Inc.

WebsiteLinkedInAll Job Openings

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

• Reporting to the Director - Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites. • The Clinical Research Associate (CRA) will execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs). • 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. • Manages query resolution process with clinical sites and data management groups. • Travel of up to 75% may be required, including globally. Quarterly travel to San Diego headquarters required, if not residing locally. • Other work-related duties, special projects, and/or other functions, as required.

🎯 Requirements

• Minimum of 2 years of experience in a Clinical Trial Assistant or other supporting project role with high attention to detail (3+ years of clinical monitoring experience preferred). • Prior experience with oncological trials strongly preferred. • Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments. • Must exercise sound judgment and take initiative, be able to work independently with minimal supervision while producing accurate high quality and timely work. • Must be able to work effectively within a team environment (independently and collaboratively). • 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