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Central Study Coordinator I

6 hours, 31 minutes ago
United States
Full-time
Mid Level
Project Coordinator
Project and Program Management
GCP
Apply Now
Care Access

Care Access

Care Access is a decentralized research organization (DRO) that accelerates the future of medicine by breaking down traditional barriers in clinical research and expanding the impact of research to previously unreachable patient populations.

Diversified Consumer Services
251-1K
View All Jobs

Description

  • Perform virtual informed consent with study participants using e-consent technology and register participants in IWRS.
  • Pre-screen and educate potential study participants and their families about the study and associated disease(s).
  • Interpret patient medical history and medication use to determine pre-screening qualification.
  • Manage participant referral portals and study applications in real time in accordance with GCP.
  • Schedule, prepare for, and facilitate participant visits, including logistics, technology, and communication needs across study-related entities.
  • Perform protocol-mandated visit activities while maintaining GCP compliance.
  • Maintain study documentation across multiple study portals in accordance with ALCOA-C.
  • Enter data, resolve queries in EDC and other portals, and keep all study trackers and systems current daily.
  • Identify, document, and report adverse events and serious adverse events, and support subject safety reporting.
  • Serve as a project manager for assigned studies by hosting calls with PIs, preparing agendas and minutes, following up on action items, and facilitating communication among sites, CRAs, and sponsors.

Requirements

  • At least 3 years of relevant clinical research experience.
  • Bachelor’s degree preferred, or equivalent combination of education, training, and experience.
  • Strong working knowledge of the clinical research industry.
  • Ability to navigate and troubleshoot clinical research technologies, including recruitment platforms, IWRS, EDC, and other trial software.
  • Proficiency with Microsoft Office applications, including Word, Outlook, Teams, and Excel.
  • Excellent understanding of government regulations, GCP, and ALCOA-C.
  • Proficiency in research terminology and basic medical terminology.
  • Strong organization, time management, attention to detail, communication, and customer service skills.
  • Ability to work effectively in a fast-paced, remote environment.
  • Proper home office setup, including a private space for participant communication and high-speed internet (minimum 100MB up and 15 MB down with a 5 GHz router).
  • CCRC preferred.
  • Fluency in Spanish is a bonus.

Benefits

  • Expected pay range of $75,000 to $95,000 USD per year for full-time team members.
  • Paid time off 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 and long-term disability coverage.
  • 401(k) retirement plan with company match.

Interested in this position?

Apply directly on the company website

Apply Now

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