CRO – Clinical Trials Assistant

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

📊 Conversion Rate Optimizer (CRO)

🚫👨‍🎓 No degree required

👻 Ghost score 12%

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Support Clinical Operations to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines • Archive and organize clinical trial master file documents, including clinical study site documents • Generate filing indexes and maintain current correspondence lists • Assist with regulatory document templates, study binders, study communications, and presentations • Manage clinical, regulatory, and study-related essential documents, including study protocols and Informed Consent Forms • Assist with initial study drug release, including regulatory packet review and study-drug release • Prepare study-specific training materials • Participate in investigator meeting planning • Interact with sites to respond to issues • Handle incoming and outgoing shipments as needed • Monitor and track monitoring visit reports • Track clinical trial progress and prepare status update reports • Participate in clinical data review at case report form, data listing, and report table levels • Collect weekly enrollment updates and reports • Assist the Project Manager with project meeting setup and preparation, including scheduling calls, gathering updates, preparing agendas, and drafting minutes • File and quality-control trial master files • Ensure timely and accurate filing/uploading of documents into the eTMF • Review and maintain study-team training records • Update study team member changes and the Study Contact Sheet • Complete Study Plan Checklists as assigned • Identify and escalate issues appropriately • Act as a central contact for designated project communications and documentation • Perform data entry into designated clinical tracking systems • Perform other related duties as required

🎯 Requirements

• High school diploma/certificate or educational equivalent required • Minimum of 2 years of clinical research experience required • General knowledge of applicable clinical research requirements, including GCP and ICH guidelines • Strong Microsoft Office skills • Demonstrated organizational and coordination skills with attention to detail • Strong written and verbal communication skills • Effective time management and organizational skills • Attention to detail and accuracy in work • Strong customer service orientation • Ability to work effectively and efficiently handling multiple tasks simultaneously • Ability to facilitate a teamwork philosophy with a positive attitude

🏖️ Benefits

• Remote work arrangement