Central Study Coordinator, Level I

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $75k - $95k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

🍽️ Food & Beverage

🏥 Healthcare

📦 Logistics

💰 Grant on 2021-11

Food & Beverage • Healthcare • Logistics

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• Virtually support patients and clinical research sites as an extension of the research site • Support one to four sites concurrently across one or more studies • Perform virtual informed consent using e-consent technology and register participants in IWRS • Pre-screen and educate potential study participants • Analyze study protocols and associated diseases to educate patients and families • Interpret medical history and medication use to determine pre-screening qualification • Manage participant referral portals and study-specific applications in accordance with GCP • Schedule, prepare for, and facilitate participant visits and related logistics, technology, and communications • Perform protocol-mandated visit activities while maintaining GCP compliance • Maintain study documentation in accordance with ALCOA-C across multiple study portals • Collect sensitive data and create, manage, secure, and transmit source documentation • Enter data and resolve queries in EDC and other portals within study-defined timelines • Identify, document, and report Adverse Events and Serious Adverse Events • Keep study trackers and systems updated daily and support subject safety reporting • Manage study work for assigned sites as delegated by the PI across multiple protocols • Host regular calls with assigned PIs and present study updates • Prepare agendas, circulate minutes, and follow up on action items • Facilitate communication between study sites, CRAs, and sponsors • Build rapport with sites, participants, CRAs, and sponsor contacts • Perform quality checks, complete ongoing training, and analyze study protocols

🎯 Requirements

• Bachelor’s Degree preferred, or equivalent combination of education, training and experience • At least 3 years of relevant clinical research experience • Fluency in Spanish is a bonus • CCRC preferred • Ability to navigate and troubleshoot clinical research technologies, including recruitment platforms, IWRS, EDC, and other clinical trial software • Proficient with Microsoft Office applications (Word, Outlook, Teams, and Excel) • Proficient in research terminology and basic medical terminology • Working knowledge of the clinical development paradigm, government regulations, GCP, and ALCOA-C • Strong organization and time management skills • High attention to detail • Ability to work in a fast-paced and remote environment • Critical thinking and problem-solving ability • Proper home office setup with a private space and high-speed internet (minimum 100MB up and 15MB down, 5 GHz router) • Care Access is unable to sponsor work visas at this time

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match